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# MEDIZONE

Global Pharma Sourcing

## Sitemaps

- [XML Sitemap](https://medizone.com/sitemap.xml): Contains all public & indexable URLs for this website.

## Beiträge

- [Save the date - ADKA-Herstellungssymposium Fulda 19. - 20. November 2026](https://medizone.com/save-the-date-adka-herstellungssymposium-19-20-nov-fulda/) - Meet us at ADKA-Herstellungssymposium Fulda 19. - 20. November 2026. Please contact: Robin Mangler – Mobile: +49 174 210 0943 – robin.mangler@medizone.com Florian Holländer – Mobile: +49 173 7388 146 – florian.hollaender@medizone.com Or Dial +49 89 1211 2636 and we’ll be happy to arrange an appointment.
- [Save the date - ADKA-Herstellungssymposium Fulda 19. - 20. November 2026](https://medizone.com/en/save-the-date-adka-herstellungssymposium-19-20-nov-fulda/) - Meet us at ADKA-Herstellungssymposium Fulda 19. - 20. November 2026. Please contact: Robin Mangler – Mobile: +49 174 210 0943 – robin.mangler@medizone.com Florian Holländer – Mobile: +49 173 7388 146 – florian.hollaender@medizone.com Or Dial +49 89 1211 2636 and we’ll be happy to arrange an appointment.
- [Meet us at expopharm Munich 15.-17. September 2026](https://medizone.com/save-the-date-expopharm-munich-15-17-september-2026/) - We will have a booth again this year at expopharm Munich, hall A3 - IMP, booth D56 – 15.-17. September 2026, and hope that we can welcome you again. Please contact: Robin Mangler - Head of Sales & Sourcing robin.mangler@medizone.com Florian Holländer - Head of Unlicensed Medicines & Named Patient Import florian.hollaender@medizone.com Lucy Kosch - Senior Account Manager
- [Meet us at expopharm Munich 15.-17. September 2026](https://medizone.com/en/save-the-date-expopharm-munich-15-17-september-2026/) - We will have a booth again this year at expopharm Munich, hall A3- IMP, booth D56 – 15.-17. September 2026, and hope that we can welcome you again. Please contact: Robin Mangler - Head of Sales & Sourcing robin.mangler@medizone.com Florian Holländer - Head of Unlicensed Medicines & Named Patient Import florian.hollaender@medizone.com Lucy Kosch - Senior Account Manager lucy.kosch@medizone.com
- [Meet us at CPHI Frankfurt 28.-30. October 2025](https://medizone.com/en/meet-us-at-cphi-frankfurt-28-30-october-2025/) - We are looking forward to Meet us at CPHI in Frankfurt 28th - 30th of October 2025. We’ll be happy to arrange an appointment. Klajdi Drini Head of EU Sales Mobile/ WhatsApp: +49 173 36 40 40 5 MAIL: klajdi.drini@medizone.com Simona E. Manolovici Sales Coordinator MAIL: simona.manolovici@medizone.com
- [Meet us at Infarma Madrid 24.-26.03.2026](https://medizone.com/meet-us-at-infarma-madrid-24-26-03-2026/) - We are looking forward to meet you at Infarma Madrid 24.-26.3.2026 Please contact: Lucy Kosch - Account Manager - Mobile: +49 173 6318170 - Lucy.Kosch@medizone.com Agnieszka Dobrowlanska - Account Manager - Mobile: +49 172 456 6642 - Agnieszka.Dobrowlanska@medizone.com Or Dial +49 89 1211 2636 and we’ll be happy to arrange an appointment.
- [Meet us at ADKA "Regionalkongress Süd" Neu-Ulm 27.-28.02.2026](https://medizone.com/en/meet-us-at-adka-regionalkongress-sued-neu-ulm-27-28-02-2026/) - We are looking forward to meet you at ADKA "Regionalkongress" Neu-Ulm 27.-28.2.2026 Please contact: Robin Mangler - Mobile: +49 174 210 0943 - robin.mangler@medizone.com Florian Holländer - Mobile: +49 173 7388 146 - florian.hollaender@medizone.com Or Dial +49 89 1211 2636 and we’ll be happy to arrange an appointment.
- [Meet us at ADKA "Regionalkongress Süd" Neu-Ulm 27.-28.02.2026](https://medizone.com/meet-us-at-adka-regionalkongress-sued-neu-ulm-27-28-02-2026/) - We are looking forward to meet you at ADKA "Regionalkongress" Neu-Ulm 27.-28.2.2026 Please contact: Robin Mangler - Mobile: +49 174 210 0943 - robin.mangler@medizone.com Florian Holländer - Mobile: +49 173 7388 146 - florian.hollaender@medizone.com Or Dial +49 89 1211 2636 and we’ll be happy to arrange an appointment.
- [Meet us at Infarma Madrid 24.-26.03.2026](https://medizone.com/en/meet-us-at-infarma-madrid-24-26-03-2026/) - We are looking forward to meet you at Infarma Madrid 24.-26.3.2026 Please contact: Lucy Kosch - Account Manager - Mobile: +49 173 6318170 - Lucy.Kosch@medizone.com Agnieszka Dobrowlanska - Account Manager - Mobile: +49 172 456 6642 - Agnieszka.Dobrowlanska@medizone.com Dial +49 89 1211 2636 and we’ll be happy to arrange an appointment.
- [Save the date - expopharm 16. - 18. September 2025 Düsseldorf](https://medizone.com/en/save-the-date-expopharm-16-18-september-2025/) - Save the date - we will have a booth again this year at expopharm Düsseldorf, hall 3 – IMP, booth C69, 16. - 18. September 2025, and hope that we can welcome you again. Please contact: Lucy Kosch lucy.kosch@medizone.com Robin Mangler robin.mangler@medizone.com Yulia Koch yulia.koch@medizone.com Klajdi Drini klajdi.drini@medizone.com Sebastian Hörl sebastian.hoerl@medizone.com Agnieszka Dobrowlanska agnieszka.dobrowlanska@medizone.com Dial +49
- [20 Years of Medizone - A heartfelt thank you for your trust](https://medizone.com/en/20-years-of-medizone-a-heartfelt-thank-you-for-your-trust/) - 2025 was a very special year for us. We look back on 20 years of company history - full of growth, exciting projects, and collaborative partnerships. A heartfelt thank you for your trust! We support the „Wings for Life - Spinal Cord Research Foundation" as well as the „McDonald's Children's Aid Foundation".
- [20 Jahre Medizone - Herzliches Dankeschön für Ihr Vertrauen!](https://medizone.com/20-jahre-medizone-herzliches-dankeschoen-fuer-ihr-vertrauen/) - 2025 war für uns ein ganz besonderes Jahr. Wir blicken auf 20 Jahre Firmengeschichte zurück – voller Wachstum, spannender Projekte und partnerschaftlicher Zusammenarbeit. Herzliches Dankeschön für Ihr Vertrauen! Wir unterstützen „Wings for Life – Stiftung für Rückenmarksforschung“ sowie die „McDonalds Kinderhilfe Stiftung“.
- [Meet us at CPHI Frankfurt 28. - 30. October 2025](https://medizone.com/meet-us-at-cphi-frankfurt-28-30-of-october-2025/) - We are looking forward to Meet us at CPHI in Frankfurt 28th - 30th of October 2025. We’ll be happy to arrange an appointment. Klajdi Drini Head of EU Sales Mobile/ WhatsApp: +49 173 36 40 40 5 MAIL: klajdi.drini@medizone.com Simona E. Manolovici Sales Coordinator MAIL: simona.manolovici@medizone.com
- [Save the date - expopharm 16. - 18. September 2025 in Düsseldorf](https://medizone.com/save-the-date-expopharm-16-18-september-2025/) - Save the date - we will have a booth again this year at expopharm Düsseldorf, hall 3 – IMP, booth C69, 16. - 18. September 2025, and hope that we can welcome you again. Please contact: Lucy Kosch lucy.kosch@medizone.com Robin Mangler robin.mangler@medizone.com Yulia Koch yulia.koch@medizone.com Klajdi Drini klajdi.drini@medizone.com Sebastian Hörl sebastian.hoerl@medizone.com Agnieszka Dobrowlanska agnieszka.dobrowlanska@medizone.com Dial +49
- [Meet us at Pharmagora Plus Paris 09. - 10.03.2024](https://medizone.com/en/meet-us-at-pharmagora-plus-paris-09-10-03-2024/) - We are looking forward to meet you at Pharmagora Plus Paris 09.-10.3.2024 Please contact: Birgit Glaubitz - Managing Director - birgit.glaubitz@medizone.com Lucy Kosch - Account Manager - Lucy.Kosch@medizone.com Dial +49 89 1211 2636 and we’ll be happy to arrange an appointment.
- [Meet us at Pharmagora Plus Paris 09. - 10.03.2024](https://medizone.com/meet-us-at-pharmagora-plus-paris-09-10-03-2024/) - We are looking forward to meet you at Pharmagora Plus 09.-10.3.2024 Please contact: Birgit Glaubitz - Managing Director - birgit.glaubitz@medizone.com Lucy Kosch - Account Manager - Lucy.Kosch@medizone.com Dial +49 89 1211 2636 and we’ll be happy to arrange an appointment.
- [Meet us at Infarma Barcelona 25. - 27.03.2025](https://medizone.com/meet-us-at-infarma-barcelona-25-27-03-2025/) - We are looking forward to meet you at Infarma Barcelona 25.-27.3.2025 Please contact: Lucy Kosch - Account Manager - Lucy.Kosch@medizone.com Klajdi Drini - Head of EU Sales - klajdi.drini@medizone.com Agnieszka Dobrowlanska - Account Manager - Agnieszka.Dobrowlanska@medizone.com Anna Ivankova - Anna.Ivankova@medizone.com Dial +49 89 1211 2636 and we’ll be happy to arrange an appointment.
- [Meet us at Infarma Barcelona 25. - 27.03.2025](https://medizone.com/en/meet-us-at-infarma-barcelona-25-27-03-2025/) - We are looking forward to meet you at Infarma Barcelona 25.-27.3.2025 Please contact: Lucy Kosch - Account Manager - Lucy.Kosch@medizone.com Klajdi Drini - Head of EU Sales - klajdi.drini@medizone.com Agnieszka Dobrowlanska - Account Manager - Agnieszka.Dobrowlanska@medizone.com Anna Ivankova - Anna.Ivankova@medizone.com Dial +49 89 1211 2636 and we’ll be happy to arrange an appointment.
- [Meet us at Arab Health Dubai 27. - 30.01.2025](https://medizone.com/meet-us-at-arab-health-dubai-27-30-01-2025/) - We are looking forward to meet you at Arab Health Dubai from 27. - 30.01.2025 – please contact Mr. Klajdi Drini - Head of EU Sales - klajdi.drini@medizone.com Mrs. Yulia Koch - Account Manager - yulia.koch@medizone.com Mr. Robin Mangler - Head of Sourcing - robin.mangler@medizone.com or dial +49 89 1211 2636 and we'll be happy to
- [Meet us at Arab Health Dubai 27. - 30.01.2025](https://medizone.com/en/meet-us-at-arab-health-dubai-27-30-01-2025/) - We are looking forward to meet you at Arab Health Dubai from 27. - 30.01.2025 – please contact Mr. Klajdi Drini - Head of EU Sales - klajdi.drini@medizone.com Mrs. Yulia Koch - Account Manager - yulia.koch@medizone.com Mr. Robin Mangler - Head of Sourcing - robin.mangler@medizone.com or dial +49 89 1211 2636 and we'll be happy to
- [Merry Christmas and Happy New Year](https://medizone.com/en/merry-christmas/) - The Medizone TEAM says THANK YOU for the wonderful collaboration and support. Wishing you a joyful holiday season and a fantastic start into a healthy and happy 2025. We support „Wings for Life - Foundation for Spinal Cord Research" and the „McDonald's Children's Aid Foundation".
- [Wir wünschen stimmungsvolle Feiertage und einen gelungenen Rutsch in ein gesundes und glückliches 2025](https://medizone.com/frohe-weihnachten/) - Das Medizone TEAM sagt DANKE für die wunderbare Zusammenarbeit und Unterstützung. Wir wünschen stimmungsvolle Feiertage und einen gelungenen Rutsch in ein gesundes und glückliches 2025. Wir unterstützen „Wings for Life - Stiftung für Rückenmarksforschung" sowie die „McDonalds Kinderhilfe Stiftung".
- [Meet us at CPHI Barcelona 24. – 26.10.2023](https://medizone.com/meet-us-at-cphi-barcelona-24-26-10-2023/) - We are looking forward to meet you at CPHI Barcelona from the 24th to 26th October 2023 – please contact Mr. Robin Mangler - Head of International Pharma Sales - robin.mangler@medizone.com Mrs. Yulia Koch - Account Manager - yulia.koch@medizone.com Mr. Sebastian Hoerl - Account Manager - sebastian.hoerl@medizone.com Mrs. Marianna Delgado - Account Manager - marianna.delgado@medizone.com or
- [Meet us at CPHI Barcelona 24.-26.10.2023](https://medizone.com/en/meet-us-at-cphi-barcelona-24-26-10-2023/) - We are looking forward to meet you at CPHI Barcelona from the 24th to 26th October 2023 – please contact Mr. Robin Mangler - Head of International Pharma Sales - robin.mangler@medizone.com Mrs. Yulia Koch - Account Manager - yulia.koch@medizone.com Mr. Sebastian Hoerl - Account Manager - sebastian.hoerl@medizone.com Mrs. Marianna Delgado - Account Manager - marianna.delgado@medizone.com or
- [Medizone unterstützt die McDonald's Kinderhilfe Stiftung](https://medizone.com/medizone-unterstuetzt-die-mcdonalds-kinderhilfe-stiftung/) - Wir unterstützen die McDonald's Kinderhilfe Stiftung. Im Ronald McDonald Haus in München-Großhadern können Familien ganz nah bei ihren schwer kranken Kindern sein und ihnen Liebe, Kraft und Zuversicht schenken. Medizone ermöglicht durch die Patenschaft für das Apartment 11, dass Familien schwer kranker Kinder hier ein Zuhause auf Zeit finden.
- [Medizone supports McDonald's Kinderhilfe Stiftung](https://medizone.com/medizone-unterstuetzt-die-mcdonalds-kinderhilfe-stiftung/) - We support McDonald's Kinderhilfe Stiftung. At the Ronald McDonald House in Munich-Großhadern families can be close to their badly diseased children and give them all their love and confidence. Medizone enables through the sponsorship of apartment 11, that families with seriously ill children can find a home on time.
- [Thanks for visiting us at ARAB HEALTH 2023](https://medizone.com/thanks-for-visiting-us-at-arab-health-2023/) - Thank you for visiting us at Arab Health this year! It was a great pleasure to have the opportunity again to speak in person with many of our business partners. We will be back in 2024!
- [Meet us at Pharmagora Plus - 11-12 march 2023 - Paris](https://medizone.com/meet-us-at-pharmagora-plus-11-12-march-paris/) - We are looking forward to meet you at Pharmagora Plus 11.-12.3.2023 Dial +49 89 1211 2636 and we’ll be happy to arrange an appointment.
- [Meet us at Pharmagora Plus - 11-12 march 2023 - Paris](https://medizone.com/en/meet-us-at-pharmagora-plus-11-12-march-2023-paris/) - We are looking forward to meet you at Pharmagora Plus 11.-12.3.2023 Dial +49 89 1211 2636 and we’ll be happy to arrange an appointment.
- [Thanks for visiting us at ARAB HEALTH 2023](https://medizone.com/thanks-for-visiting-us-at-arab-health-2023/) - Thank you for visiting us at Arab Health this year! It was a great pleasure to have the opportunity again to speak in person with many of our business partners. We will be back in 2024!
- [Meet us at CPhI 2021 - Milan 9th to 11th November](https://medizone.com/meet-us-at-cphi-2021-milan-9th-to-11th-november/) - We are looking forward to meet you at CPhI Milan from the 9th to 11th November 2021 – please contact Mr. Robin Mangler - Head of International Pharma Sales - robin.mangler@medizone.com Mr. Klajdi Drini - Sales Support Manager - klajdi.drini@medizone.com or dial +49 89 1211 2636 and we'll be happy to arrange an appointment. For more information visit
- [Russia registers new Covid-19 drug to keep complications caused by virus ‘under control’](https://medizone.com/russia-registers-new-covid-19-drug-to-keep-complications-caused-by-virus-under-control/) - Russian developers have registered a new drug that may help alleviate the harshest complications caused by Covid-19, including lung failure. It’s hoped the treatment can buy time before a vaccine is found. Levilimab is the second medication to receive state approval through a fast-track mechanism, implemented to give doctors more options to tackle the virus,
- [Cancellation expopharm 2021](https://medizone.com/expopharm-22nd-25th-september-2021-will-take-place/) - Cancellation expopharm 2021 - largest European trade fair in Düsseldorf will not take place.
- [Meet us at CPhI 2021 - Milan 9th to 11th November](https://medizone.com/en/meet-us-at-cphi-2021-milan-9th-to-11th-november/) - We are looking forward to meet you at CPhI Milan from the 9th to 11th November 2021 – please contact Mr. Robin Mangler - Head of International Pharma Sales - robin.mangler@medizone.com Mr. Klajdi Drini - Sales Support Manager - klajdi.drini@medizone.com or dial +49 89 1211 2636 and we'll be happy to arrange an appointment. For more information visit
- [Meet us at Expopharm 2022 - Munich 14th to 17th September](https://medizone.com/en/meet-us-at-expopharm-2022-munich-14th-to-17th-september/) - We will have a booth again this year at expopharm Munich, 14th to 17th September, and hope that we can welcome you again in Hall B2 / Booth C28.
- [Meet us at Expopharm 2022 - München 14th to 17th September](https://medizone.com/meet-us-at-expopharm-2022-muenchen-14th-to-17th-september/) - We will have a booth again this year at expopharm München and hope that we can welcome you again in Hall B2 / Booth C28.
- [Meet us at CTS Europe 2022 – Madrid 22.-23.3.](https://medizone.com/en/meet-us-at-cts-europe-2022-madrid-22-23-3/) - We are looking forward to meet you at CTS Europe 2022 from 22.-23.3.2022 – please contact Mrs. Cinzi Adorni – Account Manager CTS – cinzia.adorni@medizone.com Mr. Gerhard Hoerl – Manging Director – Gerhard.hoerl@medizone.com or dial +49 89 1211 2636 and we’ll be happy to arrange an appointment.
- [Meet us at CTS Europe 2022 – Madrid 22.-23.3.](https://medizone.com/meet-us-at-cts-europe-2022-madrid-22-23-3/) - We are looking forward to meet you at CTS Europe 2022 from 22.-23.3.2022 – please contact Mrs. Cinzi Adorni – Account Manager CTS – cinzia.adorni@medizone.com Mr. Gerhard Hoerl – Manging Director – Gerhard.hoerl@medizone.com or dial +49 89 1211 2636 and we’ll be happy to arrange an appointment.
- [Absage expopharm 2021](https://medizone.com/expopharm-22nd-25th-september-2021-will-take-place/) - Absage expopharm 2021 - 22. - 25. September 2021 - Europas größte Fachmesse in Düsseldorf rund um den Apothekenmarkt wird nicht stattfinden.
- [Russia registers new Covid-19 drug to keep complications caused by virus ‘under control’](https://medizone.com/russia-registers-new-covid-19-drug-to-keep-complications-caused-by-virus-under-control/) - Russian developers have registered a new drug that may help alleviate the harshest complications caused by Covid-19, including lung failure. It’s hoped the treatment can buy time before a vaccine is found. Levilimab is the second medication to receive state approval through a fast-track mechanism, implemented to give doctors more options to tackle the virus,
- [Pharmagora Plus - Paris - cancelled June 27-28, 2020 - new dates March 13-14, 2021](https://medizone.com/meet-us-at-pharmagora-plus-paris-14-15-march-2020/) - Due to the current situation of the coronavirus epidemy, the French Minister of Health, Mr Olivier Véran, has forbidden the organization of any event with more than 5000 delegates in a closed environment. As a result, PharmogaraPlus 2020 will not take place on the 27th and 28th of June 2020 at Paris Porte de Versailles, Hall 3.
- [Pharmagora Plus - Paris - cancelled June 27-28, 2020 - new dates March 13-14, 2021](https://medizone.com/meet-us-at-pharmagora-plus-paris-14-15-march-2020/) - Due to the current situation of the coronavirus epidemy, the French Minister of Health, Mr Olivier Véran, has forbidden the organization of any event with more than 5000 delegates in a closed environment. As a result, PharmogaraPlus 2020 will not take place on the 27th and 28th of June 2020 at Paris Porte de Versailles, Hall 3.
- [We support "Wings for Life" and "Mc Donalds Kinderhilfe"](https://medizone.com/en/merry-christmas-and-a-successful-new-year/) - On behalf of our team here at Medizone, we would like to thank you for a great year. We will continue to support "Wings for Life" and "Mc Donalds Kinderhilfe". We wish you a great start into a successful New Year 2020.
- [Thanks for visiting us at ARAB HEALTH 2020 – 27 to 30 January](https://medizone.com/meet-us-at-our-booth-at-arab-health-2020-27-to-30-january/) - Thank you for visiting us at Arab Health this year! It was a great pleasure to have the opportunity again to speak in person with many of our business partners. Maktoum Hall - Booth Number M.D33 27th to 30th January 2020. For more information visit ARAB HEALTH exhibitor directory.
- [Thanks for visiting us at ARAB HEALTH 2020 – 27 to 30 January](https://medizone.com/meet-us-at-our-booth-at-arab-health-2020-27-to-30-january/) - Thank you for visiting us at Arab Health this year! It was a great pleasure to have the opportunity again to speak in person with many of our business partners. Maktoum Hall - Booth Number M.D33 27th to 30th January 2020. For more information visit ARAB HEALTH exhibitor directory.
- [We support "Wings for Life" and "Mc Donalds Kinderhilfe"](https://medizone.com/frohe-weihnachten-und-ein-erfolgreiches-neues-jahr/) - Das Medizone-Team wünscht einen guten Start in das Jahr 2020. Wir unterstützen auch in diesem Jahr "Wings for Life" und die "Mc Donalds Kinderhilfe"
- [„Wings for Life“ honors Medizone for continues support!](https://medizone.com/wings-for-life-honors-medizone-for-continues-support/) - Wings for Life – Spinal Cord Research Foundation Worldwide, millions of people are dependent on a wheelchair after having sustained a spinal cord injury, most often as the result of a traffic accident or a fall. Wings for Life is a not-for-profit spinal cord research foundation with the single mission to find the cure for
- [„Wings for Life“ honors Medizone for continues support!](https://medizone.com/wings-for-life-honors-medizone-for-continues-support/) - Wings for Life – Spinal Cord Research Foundation Worldwide, millions of people are dependent on a wheelchair after having sustained a spinal cord injury, most often as the result of a traffic accident or a fall. Wings for Life is a not-for-profit spinal cord research foundation with the single mission to find the cure for
- [Thanks for visting us at CPHI in Frankfurt](https://medizone.com/meet-us-at-cphi-in-frankfurt/) - Thank you for visiting us at CHPI in Frankfurt this year! It was a great pleasure to have the opportunity again to speak in person with many of our business partners. More information on the CHPI
- [Thanks for visting us at CPHI in Frankfurt](https://medizone.com/meet-us-at-cphi-in-frankfurt/) - Thank you for visiting us at CHPI in Frankfurt this year! It was a great pleasure to have the opportunity again to speak in person with many of our business partners.
- [Thanks for visiting us at Expopharm 2019](https://medizone.com/thanks-for-visiting-us-at-expopharm-2019/) - Thank you for visiting us at Expopharm in Düsseldorf this year! It was a great pleasure to have the opportunity again to speak in person with many of our business partners.
- [Thanks for visiting us at Expopharm 2019](https://medizone.com/thanks-for-visiting-us-at-expopharm-2019/) - Thank you for visiting us at Expopharm in Munich this year! It was a great pleasure to have the opportunity again to speak in person with many of our business partners.
- [Meet us at Expopharm 2019 - Düsseldorf 25th to 28th September](https://medizone.com/meet-us-at-expopharm-2019-duesseldorf-25th-to-28th-september/) - We will have a booth again this year at expopharm Düsseldorf and hope that we can welcome you again in Hall 3 / Booth D32 For more information visit expopharm exhibitor director
- [Meet us at Expopharm 2019 - Düsseldorf 25th to 28th September](https://medizone.com/meet-us-at-expopharm-2019-duesseldorf-25th-to-28th-september/) - We will have a booth again this year at expopharm Düsseldorf and hope that we can welcome you again in Hall 3 / Booth D32 For more information visit expopharm exhibitor director
- [Meet us at Clinical Operations in Oncology Trial Europe 2018](https://medizone.com/meet-us-at-clinical-operations-in-oncology-trial-europe-2018/) - Meet us at our Booth at Clinical Operations in Oncology Trial Europe 2018 at the Hilton Munich Airport from 14 – 15 November 2018. We look forward to meeting you there!
- [Meet us at Clinical Operations in Oncology Trial Europe 2018](https://medizone.com/meet-us-at-clinical-operations-in-oncology-trial-europe-2018/) - Meet us at our Booth at Clinical Operations in Oncology Trial Europe 2018 at the Hilton Munich Airport from 14 – 15 November 2018. We look forward to meeting you there!
- [Thanks for visiting us at Expopharm 2018!](https://medizone.com/thanks-for-visiting-us-at-expopharm-2018/) - Thank you for visiting us at Expopharm in Munich this year. It was a great pleasure to have the opportunity again to speak in person with many of our business partners. One big subject was the safety of drugs which is always our number one priority. Therefore, long-term trusting business partnerships are of great importance
- [Thanks for visiting us at Expopharm 2018!](https://medizone.com/thanks-for-visiting-us-at-expopharm-2018/) - Thank you for visiting us at Expopharm in Munich this year. It was a great pleasure to have the opportunity again to speak in person with many of our business partners. One big subject was the safety of drugs which is always our number one priority. Therefore, long-term trusting business partnerships are of great importance
- [Meet Us At Our Booth At ARAB HEALTH 2019 – 28 To 31 January](https://medizone.com/meet-us-at-our-booth-at-arab-health-2019-28-to-31-january/) - We are looking forward to welcoming you at our booth at ARAB HEALTH – Stand No. (Za’abeel Hall 3) Z3 / E.40. 28th to 31st January 2019. For more information visit ARAB HEALTH exhibitor directory.
- [Meet Us At Our Booth At ARAB HEALTH 2019 – 28 to 31 January](https://medizone.com/meet-us-at-our-booth-at-arab-health-2019-28-to-31-january/) - We are looking forward to welcoming you at our booth at ARAB HEALTH - Stand No. (Za’abeel Hall 3) Z3 / E.40. 28th to 31st January 2019. For more information visit ARAB HEALTH exhibitor directory.
- [Meet us at Expopharm - Munich 10th to 13th October](https://medizone.com/meet-us-at-expopharm-munich-10th-to-13th-october/) - We will have a booth again this year at expopharm Munich and hope that we can welcome you again in Hall B6 / Booth D17 For more information visit expopharm exhibitor director
- [Meet us at Expopharm 2018 - Munich 10th to 13th October](https://medizone.com/meet-us-at-expopharm-munich-10th-to-13th-october/) - We will have a booth again this year at expopharm Munich and hope that we can welcome you again in Hall B6 / Booth D17 For more information visit expopharm exhibitor director
- [CHMP approves pegfilgrastim biosimilar, Pelgraz from Accord/Intas](https://medizone.com/chmp-approves-pegfilgrastim-biosimilar-pelgraz-from-accord-intas/) - Pelgraz – a pegylated G-CSF biosimilar, is latest addition to Accord Healthcare’s established portfolio of over 30 oncology treatments across Europe. Following marketing authorisation Accord Healthcare will potentially be the first to launch pegfilgrastim across Europe. The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Accord’s Pelgraz (pegfilgrastim), pegylated
- [CHMP approves pegfilgrastim biosimilar, Pelgraz from Accord/Intas](https://medizone.com/chmp-approves-pegfilgrastim-biosimilar-pelgraz-from-accord-intas/) - Pelgraz – a pegylated G-CSF biosimilar, is latest addition to Accord Healthcare’s established portfolio of over 30 oncology treatments across Europe. Following marketing authorisation Accord Healthcare will potentially be the first to launch pegfilgrastim across Europe. The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Accord’s Pelgraz (pegfilgrastim), pegylated
- [FDA approves Mylan and Biocon’s Fulphila, the first biosimilar to Neulasta](https://medizone.com/fda-approves-mylan-and-biocons-fulphila-the-first-biosimilar-to-neulasta/) - Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Fulphila (pegfilgrastim-jmbd), a biosimilar to Neulasta (pegfilgrastim), co-developed with Biocon. Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells)
- [FDA approves Mylan and Biocon’s Fulphila, the first biosimilar to Neulasta](https://medizone.com/fda-approves-mylan-and-biocons-fulphila-the-first-biosimilar-to-neulasta/) - Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Fulphila (pegfilgrastim-jmbd), a biosimilar to Neulasta (pegfilgrastim), co-developed with Biocon. Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells)
- [MSD launches Europe’s first biosimilar Herceptin in UK](https://medizone.com/msd-launches-europes-first-biosimilar-herceptin-in-uk/) - The first biosimilar version of Roche’s blockbuster breast cancer drug Herceptin has been launched in the UK by MSD under the Ontruzant brand name. The new biosimilar will be sold in Europe by MSD – known as Merck & Co in North America – but was originally developed by South Korean biotech Samsung Bioepis. Merck
- [MSD launches Europe’s first biosimilar Herceptin in UK](https://medizone.com/msd-launches-europes-first-biosimilar-herceptin-in-uk/) - The first biosimilar version of Roche’s blockbuster breast cancer drug Herceptin has been launched in the UK by MSD under the Ontruzant brand name. The new biosimilar will be sold in Europe by MSD – known as Merck & Co in North America – but was originally developed by South Korean biotech Samsung Bioepis. Merck
- [Medizone supports “Wings for Life” – research into spinal cord injury](https://medizone.com/medizone-supports-wings-for-life-research-into-spinal-cord-injury/) - Wings for Life - Spinal Cord Research Foundation Worldwide, millions of people are dependent on a wheelchair after having sustained a spinal cord injury, most often as the result of a traffic accident or a fall. Wings for Life is a not-for-profit spinal cord research foundation with the single mission to find the cure for
- [Medizone supports “Wings for Life” – research into spinal cord injury](https://medizone.com/medizone-supports-wings-for-life-research-into-spinal-cord-injury/) - Wings for Life - Spinal Cord Research Foundation Worldwide, millions of people are dependent on a wheelchair after having sustained a spinal cord injury, most often as the result of a traffic accident or a fall. Wings for Life is a not-for-profit spinal cord research foundation with the single mission to find the cure for
- [FDA approves Mylan and Biocon’s Ogivri, the first biosimilar for trastuzumab in the USA](https://medizone.com/fda-approves-mylan-and-biocons-ogivri-the-first-biosimilar-for-trastuzumab-in-the-usa/) - Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Ogivri™ (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab), co-developed with Biocon. Ogivri has been approved for all indications included in the label of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric
- [FDA approves Mylan and Biocon’s Ogivri, the first biosimilar for trastuzumab in the USA](https://medizone.com/fda-approves-mylan-and-biocons-ogivri-the-first-biosimilar-for-trastuzumab-in-the-usa/) - Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Ogivri™ (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab), co-developed with Biocon. Ogivri has been approved for all indications included in the label of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric
- [Samsung Bioepis’ Herceptin biosimilar received final European approval](https://medizone.com/samsung-bioepis-herceptin-biosimilar-received-final-european-approval/) - Samsung Bioepis Co., Ltd. announced the European Commission’s (EC) marketing authorization of Ontruzant, a biosimilar referencing Herceptin (trastuzumab), for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer. Ontruzant is the first trastuzumab biosimilar to receive regulatory approval in Europe. The EC approval of Ontruzant applies to all 28 European Union
- [Samsung Bioepis’ Herceptin biosimilar received final European approval](https://medizone.com/samsung-bioepis-herceptin-biosimilar-received-final-european-approval/) - Samsung Bioepis Co., Ltd. announced the European Commission’s (EC) marketing authorization of Ontruzant, a biosimilar referencing Herceptin (trastuzumab), for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer. Ontruzant is the first trastuzumab biosimilar to receive regulatory approval in Europe. The EC approval of Ontruzant applies to all 28 European Union
- [EUDRA GMDP DATABASE](https://medizone.com/eudra-gmdp-database-2/) - GMDP Database showing Certificates, Licenses and Non-Compliance. EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice. The EudraGMP system was launched in April 2007, for use by European Medicines Regulators. General public access via Internet is available since 2009. Information can be found about: MIA -
- [Samsung Bioepis submits Enbrel biosimilar to EMA](https://medizone.com/en/samsung-bioepis-submits-enbrel-biosimilar-to-ema/) - Samsung Bioepis Co., Ltd., announced that the Marketing Authorization Application (MAA) for its Enbrel (etanercept) biosimilar candidate, SB4 has been validated and accepted for review by European Medicines Agency (EMA). The acceptance of the MAA marks the first Enbrel biosimilar to advance into regulatory review in the European Union (EU). The MAA is based on
- [FDA approves first biosimilar Zarxio (filgrastim-sndz) from Sandoz](https://medizone.com/fda-approves-first-biosimilar-zarxio-filgrastim-sndz-from-sandoz-2/) - Sandoz is the first company to receive approval of a biosimilar in the US through the new FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act.
- [Falsified / stolen pharmaceutical products circulate in Germany!](https://medizone.com/falsified-stolen-pharmaceutical-products-circulate-in-germany-2/) - German authorities are investigating currently the incidence of falsified / stolen Biopharmaceutical products originating from Italy. According to a BKA spokesperson six products are under scrutiny – Avastin, Mabthera, Herceptin, Remicade, Alimta and Humatrope. End of April EMA already warned about falsified Herceptin circulating on the german market. Obviously the Herceptin was stolen from italian
- [Consensus Document On Biosimilar Medicines Paper Is Now Available In Five Languages](https://medizone.com/consensus-document-on-biosimilar-medicines-paper-is-now-available-in-five-languages-2/) - Brussels, 25 June 2014 - After its successful launch in May 2013, the European Consensus Information Paper What you need to know about Biosimilar Medicinal Products is now available in English, French, German, Italian, Spanish and later this summer, Portuguese. This important comprehensive paper is a result of a co-operation of all relevant European stakeholders.
- [Celltrion files for approval of trastuzumab (Herceptin) biosimilar (CT-P6) in Korea](https://medizone.com/test/) - On June 4th Celltrion officially announced that it has filed for Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration) approval of CT-P6 with same indications of the original product for breast cancer and metastatic gastric cancer. Upon receiving MFDS approval for CT-P6, Celltrion plans to launch its second mAb
- [EC published QUESTIONS AND ANSWERS to the GOOD DISTRIBUTION PRACTICE FOR MEDICINAL PRODUCTS FOR HUMAN USE](https://medizone.com/the-european-commission-health-and-consumers-directorate-general/) - The EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and Medicinal products – quality, safety and efficacy Has published additional information to the GDP 2013/C 343/01 GOOD DISTRIBUTION PRACTICE FOR MEDICINAL PRODUCTS FOR HUMAN USE QUESTIONS AND ANSWERS VERSION 1.0 The documents sets out frequently-asked 'questions and answers' regarding the new guidelines on Good Distribution
- [Biocon-Mylan's Biosimilar of Herceptin approved in India](https://medizone.com/en/biocon-mylans-biosimilar-of-herceptin-approved-in-india/) - Biocon, India’s largest listed biotechnology company, informed it had received marketing authorisation from the Drugs Controller General of India (DCGI) for its trastuzumab biosimilar, being developed jointly with US’ Mylan, for the treatment of HER2+ metastatic breast cancer. The product will be launched during the last quarter of this financial year. This is the first
- [Biocad’s biosimilar rituximab receives approval in Russia](https://medizone.com/biocads-biosimilar-rituximab-receives-approval-in-russia-2/) - The rituximab biosimilar which will be marketed under the trade name AcellBia, is the first mAb biosimilar to receive positive opinion from the Russian regulatory body. The Russian MoH’s positive opinion on AcellBia is based on the results of randomized multicenter clinical study comparing the pharmacokinetics, pharmacodynamics, safety, and efficacy of BCD-020 (rituximab biosimilar by
- [Medizone and PassionBio agree on closer cooperation](https://medizone.com/medizone-and-passionbio-agree-on-closer-cooperation-2/) - PassionBio’s provides drug development, regulatory and commercial solutions for biologics, biosimilar/-better or mAb programs.
- [First Infliximab Biosimilar registered in India](https://medizone.com/first-infliximab-biosimilar-registered-in-india-2/) - EPIRUS Biopharmaceuticals, Inc. announced that it has received final marketing and manufacturing approvals for its Remicade (infliximab) biosimilar, BOW015, from the Drug Controller General of India (DCGI). BOW015 is the first infliximab biosimilar approved in India. BOW015 is a biosimilar to Remicade, which is marketed globally for the treatment of inflammatory diseases including rheumatoid arthritis,
- [Comparator Sourcing Medizone - Splendid similarities - WorldPharma](https://medizone.com/en/medizone-splendid-similarities-worldpharma-comparator-sourcing/) - The benefits of biosimilars have long been championed in the medical sector, but with their use set to increase in emerging economies, securing the ever-expanding cold chain becomes more important.
- [Epirus expands biosimilar pipeline and capabilities](https://medizone.com/en/epirus-expands-biosimilar-pipeline-and-capabilities/) - Epirus Biopharmaceuticals, Inc., announced an agreement for the acquisition of Bioceros Holding B.V.
- [Samsung Bioepis wins EMA nod for the first etanercept biosimilar in the European Union](https://medizone.com/samsung-bioepis-wins-ema-nod-for-the-first-etanercept-biosimilar-in-the-european-union-2/) - Samsung Bioepis Co., Ltd. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Benepali – a biosimilar version of Enbrel® (etanercept). The drug, previously known as SB4 – for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis)
- [Amgen Biosimilars: First submission for Humira biosimilar in the United States](https://medizone.com/amgen-biosimilars-first-submission-for-humira-biosimilar-in-the-united-states-2/) - Amgen believes this submission is the first adalimumab biosimilar application submitted to the FDA and represents Amgen’s first BLA submission using the 351(k) biosimilar pathway.
- [Epirus to sell CHO platform and biosimilar IP to Polpharma](https://medizone.com/epirus-to-sell-cho-platform-and-biosimilar-ip-to-polpharma/) - As part of a cost-savings restructure, Epirus is selling the assets from its $14m acquisition of Bioceros last September to its biosimilars partner Polpharma. Last year , Epirus Biopharmaceuticals paid $14m (€12.5m) for Netherlands-based Bioceros Holding BV, adding three biosimilar candidates and a proprietary Chinese hamster ovary (CHO) platform (CHO) for the manufacture of monoclonal
- [Coherus BioSciences announces positive Phase III results for CHS-1420 (Humira biosimilar candidate) in psoriasis patients](https://medizone.com/coherus-biosciences-announces-positive-phase-iii-results-for-chs-1420-humira-biosimilar-candidate-in-psoriasis-patients/) - Coherus BioSciences, Inc., reported topline results from an ongoing Phase 3 clinical study of CHS-1420, an adalimumab (Humira) biosimilar candidate. The study met its primary endpoint demonstrating similarity between CHS-1420 and Humira with respect to percentage of subjects achieving 75% improvement in psoriasis area and severity index (PASI-75) at Week 12. The 95% confidence intervals
- [FDA approves Sandoz’ Enbrel Biosimilar](https://medizone.com/fda-approves-sandoz-enbrel-biosimilar/) - The U.S. Food and Drug Administration approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998. The newly approved drug was developed by Novartis’ Sandoz Division. Erelzi is administered by injection for the treatment of: moderate to severe rheumatoid arthritis, either as a standalone therapy
- [Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe](https://medizone.com/sandoz-proposed-biosimilars-rituximab-and-etanercept-recommended-for-approval-in-europe/) - Sandoz, announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both Sandoz’ biosimilar rituximab and biosimilar etanercept in Europe. The products are recommended to treat the same indications as their respective reference medicines. “We are proud to help patients in Europe with blood cancers
- [Mylan and Biocon filed the biosimilar Herceptin application to FDA](https://medizone.com/mylan-and-biocon-filed-the-biosimilar-herceptin-application-to-fda/) - Mylan N.V. and Biocon Ltd. last week announced submission of Mylan’s biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, to the U.S. Food and Drug Administration (FDA) through the 351(K) pathway. This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers. Mylan and
- [Meet us at our booth at expopharm 2017 - 13th to 16th September](https://medizone.com/meet-us-at-our-booth-at-expopharm-2017-13th-to-16th-september/) - We are looking forward to welcoming you at our booth at expopharm 2017 - 13th to 16th September Medizone - Hall 5 - Booth A23 For more information visit expopharm exhibitor directory.
- [Meet us at our booth at ARAB HEALTH 2017 - 30th Jan to 2nd Feb](https://medizone.com/meet-us-at-our-booth-at-arab-health-2017-30th-jan-to-2nd-feb/) - We are looking forward to welcoming you at our booth at ARAB HEALTH - Stand No. Z3.E39 in the "German Hall". 30th January to 2nd February 2017. For more information visit ARAB HEALTH exhibitor directory.
- [Samsung Bioepis first to receive EC approval for its third anti-TNF biosimilar](https://medizone.com/samsung-bioepis-first-to-receive-ec-approval-for-its-third-anti-tnf-biosimilar/) - Samsung Bioepis Co., Ltd. last week announced the European Commission’s (EC) approval of Imraldi, a biosimilar referencing Humira (adalimumab). Imraldi is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis and uveitis. With the
- [FDA approves Inflectra, a biosimilar to Remicade](https://medizone.com/fda-approves-inflectra-a-biosimilar-to-remicade/) - The U.S. Food and Drug Administration approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA. Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998. Inflectra is approved and can be prescribed by a health care professional for the
- [Samsung Bioepis first to receive EC approval for its third anti-TNF biosimilar](https://medizone.com/samsung-bioepis-first-to-receive-ec-approval-for-its-third-anti-tnf-biosimilar/) - Samsung Bioepis Co., Ltd. last week announced the European Commission’s (EC) approval of Imraldi, a biosimilar referencing Humira (adalimumab). Imraldi is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis and uveitis. With the
- [Meet us at our booth at expopharm 2017 - 13th to 16th September](https://medizone.com/meet-us-at-our-booth-at-expopharm-2017-13th-to-16th-september/) - We are looking forward to welcoming you at our booth at expopharm 2017 - 13th to 16th September Medizone - Hall 5 - Booth A23 For more information visit expopharm exhibitor directory.
- [FDA rejects Coherus’ biosimilar application for Amgen’s Neulasta](https://medizone.com/fda-rejects-coherus-biosimilar-application-for-amgens-neulasta/) - Coherus BioSciences, Inc., announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for its biologics license application for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate, under the 351(k) pathway. The CRL primarily focused on the FDA request for a reanalysis of a subset of subject samples with a revised
- [FDA rejects Coherus’ biosimilar application for Amgen’s Neulasta](https://medizone.com/fda-rejects-coherus-biosimilar-application-for-amgens-neulasta/) - Coherus BioSciences, Inc., announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for its biologics license application for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate, under the 351(k) pathway. The CRL primarily focused on the FDA request for a reanalysis of a subset of subject samples with a revised
- [Sandoz gains EU approval for biosimilar version of Roche’s MabThera](https://medizone.com/sandoz-gains-eu-approval-for-biosimilar-version-of-roches-mabthera/) - Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, announced that the European Commission (EC) has approved Rixathon (biosimilar rituximab) for use in Europe. Rixathon is approved for use in all indications of the reference medicine, MabThera. Rixathon is approved for non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic
- [Sandoz gains EU approval for biosimilar version of Roche’s MabThera](https://medizone.com/sandoz-gains-eu-approval-for-biosimilar-version-of-roches-mabthera/) - Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, announced that the European Commission (EC) has approved Rixathon (biosimilar rituximab) for use in Europe. Rixathon is approved for use in all indications of the reference medicine, MabThera. Rixathon is approved for non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic
- [Cinfa Biotech announces positive top-line data from second clinical study with pegfilgrastim biosimilar candidat](https://medizone.com/cinfa-biotech-announces-positive-top-line-data-from-second-clinical-study-with-pegfilgrastim-biosimilar-candidat/) - Cinfa Biotech S.L., the biosimilars company of Cinfa Group, today announced positive top-line data from the second clinical trial with its lead development candidate B12019, a biosimilar version of Neulasta (pegfilgrastim) to treat chemotherapy-induced neutropenia. The trial demonstrated comparability of B12019 and its reference product Neulasta with regards to pharmacodynamics (PD) and immunogenicity. All primary
- [Cinfa Biotech announces positive top-line data from second clinical study with pegfilgrastim biosimilar candidat](https://medizone.com/cinfa-biotech-announces-positive-top-line-data-from-second-clinical-study-with-pegfilgrastim-biosimilar-candidat/) - Cinfa Biotech S.L., the biosimilars company of Cinfa Group, today announced positive top-line data from the second clinical trial with its lead development candidate B12019, a biosimilar version of Neulasta (pegfilgrastim) to treat chemotherapy-induced neutropenia. The trial demonstrated comparability of B12019 and its reference product Neulasta with regards to pharmacodynamics (PD) and immunogenicity. All primary
- [Meet us at our booth at ARAB HEALTH 2017 - 30th Jan to 2nd Feb](https://medizone.com/meet-us-at-our-booth-at-arab-health-2017-30th-jan-to-2nd-feb/) - We are looking forward to welcoming you at our booth at ARAB HEALTH - Stand No. Z3.E39 in the "German Hall". 30th January to 2nd February 2017. For more information visit ARAB HEALTH exhibitor directory.
- [Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe](https://medizone.com/sandoz-proposed-biosimilars-rituximab-and-etanercept-recommended-for-approval-in-europe/) - Sandoz, announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both Sandoz’ biosimilar rituximab and biosimilar etanercept in Europe. The products are recommended to treat the same indications as their respective reference medicines. “We are proud to help patients in Europe with blood cancers
- [Comparator Sourcing - Clinical Trials - Medizone](https://medizone.com/en/comparator-sourcing-clinical-trials/) - Medizone as a strategic comparator sourcing partner for clinical trials and specialist for biosimilars focusses on integrated customized solutions.
- [Epirus expands biosimilar pipeline and capabilities](https://medizone.com/epirus-expands-biosimilar-pipeline-and-capabilities-2/) - Epirus Biopharmaceuticals, Inc., announced an agreement for the acquisition of Bioceros Holding B.V., enabling Epirus to expand its biosimilar pipeline and vertically integrate product development capabilities. From the Bioceros platform, Epirus will expand its pipeline with the addition of three preclinical product candidates: BOW080, a proposed biosimilar to eculizumab (reference biologic Soliris); BOW090, a proposed
- [Biocad announces the trastuzumab biosimilar approval in Russia](https://medizone.com/biocad-announces-the-trastuzumab-biosimilar-approval-in-russia-2/) - The trastuzumab biosimilar, to be marketed under the trade name HERtiCAD, is the first trastuzumab biosimilar to receive authorization from the Russian regulatory body.
- [EMA accepts Sandoz’s pegfilgrastim submission](https://medizone.com/ema-accepts-sandozs-pegfilgrastim-submission/) - Sandoz, announced that EMA has accepted their Marketing Authorization Application for its biosimilar to Amgen’s EU-licensed Neulasta (pegfilgrastim) – a long-acting recombinant human granulocyte colony-stimulating factor (G-CSF). Sandoz is seeking approval for the same indication as the reference product. Pegfilgrastim is a prescription medicine used in cancer patients (except those with chronic myeloid leukemia and
- [FDA approves Inflectra, a biosimilar to Remicade](https://medizone.com/fda-approves-inflectra-a-biosimilar-to-remicade/) - The U.S. Food and Drug Administration approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA. Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998. Inflectra is approved and can be prescribed by a health care professional for the
- [Epirus to sell CHO platform and biosimilar IP to Polpharma](https://medizone.com/epirus-to-sell-cho-platform-and-biosimilar-ip-to-polpharma/) - As part of a cost-savings restructure, Epirus is selling the assets from its $14m acquisition of Bioceros last September to its biosimilars partner Polpharma. Last year , Epirus Biopharmaceuticals paid $14m (€12.5m) for Netherlands-based Bioceros Holding BV, adding three biosimilar candidates and a proprietary Chinese hamster ovary (CHO) platform (CHO) for the manufacture of monoclonal
- [Coherus BioSciences announces positive Phase III results for CHS-1420 (Humira biosimilar candidate) in psoriasis patients](https://medizone.com/coherus-biosciences-announces-positive-phase-iii-results-for-chs-1420-humira-biosimilar-candidate-in-psoriasis-patients/) - Coherus BioSciences, Inc., reported topline results from an ongoing Phase 3 clinical study of CHS-1420, an adalimumab (Humira) biosimilar candidate. The study met its primary endpoint demonstrating similarity between CHS-1420 and Humira with respect to percentage of subjects achieving 75% improvement in psoriasis area and severity index (PASI-75) at Week 12. The 95% confidence intervals
- [FDA approves Sandoz’ Enbrel Biosimilar](https://medizone.com/fda-approves-sandoz-enbrel-biosimilar/) - The U.S. Food and Drug Administration approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998. The newly approved drug was developed by Novartis’ Sandoz Division. Erelzi is administered by injection for the treatment of: moderate to severe rheumatoid arthritis, either as a standalone therapy
- [Mylan and Biocon filed the biosimilar Herceptin application to FDA](https://medizone.com/mylan-and-biocon-filed-the-biosimilar-herceptin-application-to-fda/) - Mylan N.V. and Biocon Ltd. last week announced submission of Mylan’s biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, to the U.S. Food and Drug Administration (FDA) through the 351(K) pathway. This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers. Mylan and
- [Comparator Sourcing - Clinical Trials - Medizone](https://medizone.com/comparator-sourcing-clinical-trials/) - Medizone as a strategic comparator sourcing partner for clinical trials and specialist for biosimilars focusses on integrated customized solutions.
- [EMA accepts Sandoz’s pegfilgrastim submission](https://medizone.com/ema-accepts-sandozs-pegfilgrastim-submission/) - Sandoz, announced that EMA has accepted their Marketing Authorization Application for its biosimilar to Amgen’s EU-licensed Neulasta (pegfilgrastim) – a long-acting recombinant human granulocyte colony-stimulating factor (G-CSF). Sandoz is seeking approval for the same indication as the reference product. Pegfilgrastim is a prescription medicine used in cancer patients (except those with chronic myeloid leukemia and
- [Biocad announces the trastuzumab biosimilar approval in Russia](https://medizone.com/biocad-announces-the-trastuzumab-biosimilar-approval-in-russia-2/) - The trastuzumab biosimilar, to be marketed under the trade name HERtiCAD, is the first trastuzumab biosimilar to receive authorization from the Russian regulatory body.
- [FDA approves first biosimilar Zarxio (filgrastim-sndz) from Sandoz](https://medizone.com/fda-approves-first-biosimilar-zarxio-filgrastim-sndz-from-sandoz-2/) - Sandoz, a Novartis company, announced that the US Food and Drug Administration (FDA) approved Zarxio (filgrastim-sndz) for all indications included in the reference product’s label. Sandoz is the first company to receive approval of a biosimilar in the US through the new FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act. The
- [Comparator Sourcing Medizone – Splendid Similarities – WorldPharma](https://medizone.com/medizone-splendid-similarities-worldpharma-comparator-sourcing-2/) - Splendid similarities - The benefits of biosimilars have long been championed in the medical sector, but with their use set to increase in emerging economies, securing the ever-expanding cold chain becomes more important.
- [Samsung Bioepis submits Enbrel biosimilar to EMA](https://medizone.com/samsung-bioepis-submits-enbrel-biosimilar-to-ema-2/) - Samsung Bioepis Co., Ltd., announced that the Marketing Authorization Application (MAA) for its Enbrel (etanercept) biosimilar candidate, SB4 has been validated and accepted for review by European Medicines Agency (EMA). The acceptance of the MAA marks the first Enbrel biosimilar to advance into regulatory review in the European Union (EU). The MAA is based on
- [Ranbaxy launches first Biosimilar Infliximab in India!](https://medizone.com/ranbaxy-launches-first-biosimilar-infliximab-in-india-2/) - Ranbaxy Laboratories Limited (Ranbaxy), one of India’s largest pharmaceutical company, announced on 1.12.2014 the launch of Infimab (BOW015), the first Remicade (infliximab) biosimilar in India. Infimab, is being introduced in the Indian market through a licensing partnership with Epirus Biopharmaceuticals, Inc. a US and Swiss-based biopharmaceutical company focused on the global development and commercialization of
- [First Infliximab Biosimilar registered in India](https://medizone.com/first-infliximab-biosimilar-registered-in-india-2/) - EPIRUS Biopharmaceuticals, Inc. announced that it has received final marketing and manufacturing approvals for its Remicade (infliximab) biosimilar, BOW015, from the Drug Controller General of India (DCGI). BOW015 is the first infliximab biosimilar approved in India. BOW015 is a biosimilar to Remicade, which is marketed globally for the treatment of inflammatory diseases including rheumatoid arthritis,
- [FDA Accepts Sandoz Application for Biosimilar Filgrastim](https://medizone.com/fda-accepts-sandoz-application-for-biosimilar-filgrastim-2/) - Sandoz, a Novartis Group company, has announced that FDA has accepted its Biologics Licence Application for filgrastim, which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The reference product — Amgen's Neupogen — is indicated to decrease the incidence of infection, as manifested by
- [Consensus Document On Biosimilar Medicines Paper Is Now Available In Five Languages](https://medizone.com/consensus-document-on-biosimilar-medicines-paper-is-now-available-in-five-languages-2/) - Brussels, 25 June 2014 - After its successful launch in May 2013, the European Consensus Information Paper What you need to know about Biosimilar Medicinal Products is now available in English, French, German, Italian, Spanish and later this summer, Portuguese. This important comprehensive paper is a result of a co-operation of all relevant European stakeholders.
- [Falsified / stolen pharmaceutical products circulate in Germany!](https://medizone.com/falsified-stolen-pharmaceutical-products-circulate-in-germany-2/) - German authorities are investigating currently the incidence of falsified / stolen Biopharmaceutical products originating from Italy. According to a BKA spokesperson six products are under scrutiny – Avastin, Mabthera, Herceptin, Remicade, Alimta and Humatrope. End of April EMA already warned about falsified Herceptin circulating on the german market. Obviously the Herceptin was stolen from italian
- [Biocad’s biosimilar rituximab receives approval in Russia](https://medizone.com/biocads-biosimilar-rituximab-receives-approval-in-russia-2/) - The rituximab biosimilar which will be marketed under the trade name AcellBia, is the first mAb biosimilar to receive positive opinion from the Russian regulatory body. The Russian MoH’s positive opinion on AcellBia is based on the results of randomized multicenter clinical study comparing the pharmacokinetics, pharmacodynamics, safety, and efficacy of BCD-020 (rituximab biosimilar by
- [EUDRA GMDP DATABASE](https://medizone.com/eudra-gmdp-database-2/) - GMDP Database showing Certificates, Licenses and Non-Compliance. EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice. The EudraGMP system was launched in April 2007, for use by European Medicines Regulators. General public access via Internet is available since 2009. Information can be found about: MIA -
- [EC published QUESTIONS AND ANSWERS to the GOOD DISTRIBUTION PRACTICE FOR MEDICINAL PRODUCTS FOR HUMAN USE ](https://medizone.com/the-european-commission-health-and-consumers-directorate-general/) - The EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and Medicinal products – quality, safety and efficacy Has published additional information to the GDP 2013/C 343/01 GOOD DISTRIBUTION PRACTICE FOR MEDICINAL PRODUCTS FOR HUMAN USE QUESTIONS AND ANSWERS VERSION 1.0 The documents sets out frequently-asked 'questions and answers' regarding the new guidelines on Good Distribution
- [Medizone and PassionBio agree on closer cooperation](https://medizone.com/medizone-and-passionbio-agree-on-closer-cooperation-2/) - PassionBio’s provides drug development, regulatory and commercial solutions for biologics, biosimilar/-better or mAb programs. Our aim is to foster cross-frontier development of your biosimilar portfolio. We support you with (pre-)clinical trial design and with your interactions with EU regulatory authorities. We help you select the right CRO and negotiate competitive budgets with CROs and other
- [New EU GDP Guidelines – Part II](https://medizone.com/new-eu-gdp-guidelines-part-ii-2/) - The “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” have been published 07.03.2013. But only a few months later the GDP had to be renewed. The new version 2013/C 343/01 “corrects factual mistakes identified in subchapters 5.5 and 6.3 of the revised guidelines. It also gives more explanations on the rationale for
- [MabThera SC now approved in EU for patients with non-Hodgkin lymphoma](https://medizone.com/mabthera-sc-now-approved-in-eu-for-patients-with-non-hodgkin-lymphoma-2/) - Roche announced today that the EU Committee for Medicinal Products for Human Use (CHMP) recommended that the European Commission approve MabThera (rituximab) 1400mg solution for subcutaneous (SC) injection for the treatment of patients with common forms of non-Hodgkin lymphoma (NHL). “We are excited the MabThera SC data confirm the efficacy and safety of a significantly
- [Medizone supports “Wings for Life” Foundation](https://medizone.com/medizone-supports-wings-for-life-foundation-2/) - The driving forces behind Wings for Life are the two-time motocross world champion Heinz Kinigadner and the founder of Red Bull, Dietrich Mateschitz. In 2003, Kinigadner's son Hannes had a tragic accident at the age of 19 which left him tetraplegic. Moved by the dreadful injury, Kinigadner and Mateschitz invited leading scientists from across the world to
- [Medizone supports “Wings for Life” Foundation](https://medizone.com/medizone-supports-wings-for-life-foundation-2/) - The driving forces behind Wings for Life are the two-time motocross world champion Heinz Kinigadner and the founder of Red Bull, Dietrich Mateschitz. In 2003, Kinigadner's son Hannes had a tragic accident at the age of 19 which left him tetraplegic. Moved by the dreadful injury, Kinigadner and Mateschitz invited leading scientists from across the world to
- [Biocon-Mylan's Biosimilar of Herceptin approved in India](https://medizone.com/biocon-mylans-biosimilar-of-herceptin-approved-in-india-2/) - Biocon, India’s largest listed biotechnology company, informed it had received marketing authorisation from the Drugs Controller General of India (DCGI) for its trastuzumab biosimilar, being developed jointly with US’ Mylan, for the treatment of HER2+ metastatic breast cancer. The product will be launched during the last quarter of this financial year. This is the first
- [Apotex Canada received its first Biosimilar registration in Europe of Amgen's blockbuster cancer treatment filgrastim!](https://medizone.com/apotex-canada-received-its-first-biosimilar-registration-in-europe-of-amgens-blockbuster-cancer-treatment-filgrastim-2/) - Apotex's version of filgrastim received regulatory approval from the European Commission. Out-of-patent filgrastim, a biologic drug branded as Neupogen by Amgen and as Grastofil by Apotex, is used to boost production of infection-fighting white blood cells in certain cancer patients receiving chemotherapy. The product will be marketed by Stada in nearly all European Union countries.
- [New EU GDP Guidelines of 07.03.2013 - Update 08.09.2013](https://medizone.com/new-eu-gdp-guidelines-of-07-03-2013-update-08-09-2013-2/) - The “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” have been published 07.03.2013 and will apply across the European Union as of 8 September 2013. With the project “GDP-Readiness” Medizone checked all SOP’s and procedures to ensure full compliance to the new Version of the Guidelines. These are only some of the
- [Celltrion files for approval of trastuzumab (Herceptin) biosimilar (CT-P6) in Korea](https://medizone.com/test/) - On June 4th Celltrion officially announced that it has filed for Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration) approval of CT-P6 with same indications of the original product for breast cancer and metastatic gastric cancer. Upon receiving MFDS approval for CT-P6, Celltrion plans to launch its second mAb
- [EMA revised the biosimilar guideline and public consultation is now open](https://medizone.com/ema-revised-the-biosimilar-guideline-and-public-consultation-is-now-open-2/) - The European Medicines Agency (EMA) has recently published an updated biosimilars guideline for consultation that outlines the general principles that industry must take into account when developing a product and making an application to the agency. While FDA is still arguing the pathway and States are taking actions to restrict and control biosimilar entry in
- [Biosimilars require more robust analytical data](https://medizone.com/biosimilars-require-more-robust-analytical-data-2/) - At Biosimilar Drug Development conference recently held in London, Mark McCamish / Head Global Biopharmaceutical Development at Sandoz presented latest trends of the ever changing regulatory framework for Biosimilars and stressed the need for more robust biosimilarity data. This trend follows the release of the new FDA Guidelines and will have its impact on EMA
- [Cipla launches Enbrel biosimilar in India](https://medizone.com/cipla-launches-enbrel-biosimilar-in-india-2/) - Cipla has launched the first biosimilar of Pfizer and Amgen's rheumatic disorder blockbuster Enbrel in India. The company will sell its version of Enbrel (etanercept) under the brand name Etacept which will be manufactured by China's Shanghai CP Guojian Pharmaceutical Co. The drug signals Cipla's entry into the biologic segment, it said, "offering an option
- [Shortages continue](https://medizone.com/shortages-continue/) - The shortages for several oncological injectable products continue in Europe, US and several other countries. We do have close cooperation with several reputable Generic Manufacturers and deliver products with full documentation at reasonable prices. Last year we supplied bigger batches of Irinotecan, Paclitaxel, Docetaxel, Doxorubicin and Carboplatin to our customers and helped them to overcome
- [EMA To Accept Non-EU…](https://medizone.com/ema-to-accept-non-eu/) - EMA To Accept Non-EU Or Non-EEA Reference Medicinal Product RMP For Biosimilar MAAs. European Biosimilars developers will be glad to hear that the reference product of the Originators biologic, can be purchased outside the EU for comparative pivotal studies. The decision was made public by the EMA recently and the new policy should be implemented
- [New EU GDP Guidelines](https://medizone.com/new-eu-gdp-guidelines/) - We are all anxiously waiting for the final version of the new EU GDP Guidelines that are expected for release early 2013. We attended a seminar end of November in Munich to hear the latest news from the Head of our responsible inspection authorities. It looks like there will be several adaptions vs. the initial
- [New EU GDP Guidelines ](https://medizone.com/new-eu-gdp-guidelines/) - We are all anxiously waiting for the final version of the new EU GDP Guidelines that are expected for release early 2013. We attended a seminar end of November in Munich to hear the latest news from the Head of our responsible inspection authorities. It looks like there will be several adaptions vs. the initial
- [Shortages continue](https://medizone.com/shortages-continue/) - The shortages for several oncological injectable products continue in Europe, US and several other countries. We do have close cooperation with several reputable Generic Manufacturers and deliver products with full documentation at reasonable prices. Last year we supplied bigger batches of Irinotecan, Paclitaxel, Docetaxel, Doxorubicin and Carboplatin to our customers and helped them to overcome
- [Extended Services in Russia](https://medizone.com/extended-services-in-russia/) - Medizone´s partner in Russia recently opened a state-of-the-art, GxP compliant depot for study medications and clinical trial material located near Moscow not far away from Domodedovo airport. Our partner has storage capabilities in all temperature conditions: ambient, chilled, frozen and LN2. The services cover all logistical aspects: Local sourcing of comparator products and clinical trial
- [Extended Services in Russia](https://medizone.com/extended-services-in-russia/) - Medizone´s partner in Russia recently opened a state-of-the-art, GxP compliant depot for study medications and clinical trial material located near Moscow not far away from Domodedovo airport. Our partner has storage capabilities in all temperature conditions: ambient, chilled, frozen and LN2. The services cover all logistical aspects: Local sourcing of comparator products and clinical trial
- [EMA To Accept Non-EU...](https://medizone.com/ema-to-accept-non-eu/) - EMA To Accept Non-EU Or Non-EEA Reference Medicinal Product RMP For Biosimilar MAAs. European Biosimilars developers will be glad to hear that the reference product of the Originators biologic, can be purchased outside the EU for comparative pivotal studies. The decision was made public by the EMA recently and the new policy should be implemented
- [Cipla launches Enbrel biosimilar in India](https://medizone.com/cipla-launches-enbrel-biosimilar-in-india-2/) - Cipla has launched the first biosimilar of Pfizer and Amgen's rheumatic disorder blockbuster Enbrel in India. The company will sell its version of Enbrel (etanercept) under the brand name Etacept which will be manufactured by China's Shanghai CP Guojian Pharmaceutical Co. The drug signals Cipla's entry into the biologic segment, it said, "offering an option
- [Biosimilars require more robust analytical data](https://medizone.com/biosimilars-require-more-robust-analytical-data-2/) - At Biosimilar Drug Development conference recently held in London, Mark McCamish / Head Global Biopharmaceutical Development at Sandoz presented latest trends of the ever changing regulatory framework for Biosimilars and stressed the need for more robust biosimilarity data. This trend follows the release of the new FDA Guidelines and will have its impact on EMA
- [EMA revised the biosimilar guideline and public consultation is now open](https://medizone.com/ema-revised-the-biosimilar-guideline-and-public-consultation-is-now-open-2/) - The European Medicines Agency (EMA) has recently published an updated biosimilars guideline for consultation that outlines the general principles that industry must take into account when developing a product and making an application to the agency. While FDA is still arguing the pathway and States are taking actions to restrict and control biosimilar entry in
- [New EU GDP Guidelines of 07.03.2013 - Update 08.09.2013](https://medizone.com/en/new-eu-gdp-guidelines-of-07-03-2013-update-08-09-2013/) - The “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” have been published 07.03.2013 and will apply across the European Union as of 8 September 2013. With the project “GDP-Readiness” Medizone checked all SOP’s and procedures to ensure full compliance to the new Version of the Guidelines. These are only some of the
- [Apotex Canada received its first Biosimilar registration in Europe of Amgen's blockbuster cancer treatment filgrastim!](https://medizone.com/apotex-canada-received-its-first-biosimilar-registration-in-europe-of-amgens-blockbuster-cancer-treatment-filgrastim-2/) - Apotex's version of filgrastim received regulatory approval from the European Commission. Out-of-patent filgrastim, a biologic drug branded as Neupogen by Amgen and as Grastofil by Apotex, is used to boost production of infection-fighting white blood cells in certain cancer patients receiving chemotherapy. The product will be marketed by Stada in nearly all European Union countries.
- [MabThera SC now approved in EU for patients with non-Hodgkin lymphoma](https://medizone.com/en/mabthera-sc-now-approved-in-eu-for-patients-with-non-hodgkin-lymphoma/) - Roche announced today that the EU Committee for Medicinal Products for Human Use (CHMP) recommended that the European Commission approve MabThera (rituximab) 1400mg solution for subcutaneous (SC) injection for the treatment of patients with common forms of non-Hodgkin lymphoma (NHL). “We are excited the MabThera SC data confirm the efficacy and safety of a significantly
- [New EU GDP Guidelines – Part II ](https://medizone.com/new-eu-gdp-guidelines-part-ii-2/) - The “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” have been published 07.03.2013. But only a few months later the GDP had to be renewed. The new version 2013/C 343/01 “corrects factual mistakes identified in subchapters 5.5 and 6.3 of the revised guidelines. It also gives more explanations on the rationale for
- [First Etanercept biosimilar Benepali receives EU approval](https://medizone.com/first-etanercept-biosimilar-benepali-receives-eu-approval-2/) - Benepali® has been granted marketing authorization in the European Union (EU) for the treatment of adults with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis, non-radiographic axial spondyloarthritis and plaque psoriasis.
- [First Etanercept biosimilar Benepali receives EU approval](https://medizone.com/first-etanercept-biosimilar-benepali-receives-eu-approval-2/) - The joint venture between Biogen and Samsung BioLogics, Samsung Bioepis, has been granted European Commission (EC) approval for Benepali, an etanercept biosimilar referencing Enbrel. Benepali® has been granted marketing authorization in the European Union (EU) for the treatment of adults with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis, non-radiographic axial spondyloarthritis and plaque psoriasis. Biogen
- [Amgen Biosimilars: First submission for Humira biosimilar in the United States](https://medizone.com/amgen-biosimilars-first-submission-for-humira-biosimilar-in-the-united-states-2/) - Amgen announced the submission of a Biologics License Application (BLA) with the United States FDA for ABP 501, a biosimilar candidate to Humira (adalimumab). Amgen believes this submission is the first adalimumab biosimilar application submitted to the FDA and represents Amgen’s first BLA submission using the 351(k) biosimilar pathway. “The submission of Amgen’s first biosimilar
- [Samsung Bioepis wins EMA nod for the first etanercept biosimilar in the European Union](https://medizone.com/samsung-bioepis-wins-ema-nod-for-the-first-etanercept-biosimilar-in-the-european-union-2/) - Samsung Bioepis Co., Ltd. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Benepali – a biosimilar version of Enbrel® (etanercept). The drug, previously known as SB4 – for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis)
- [Cinfa Biotech treats first subjects in pegfilgrastim biosimilar clinical trial](https://medizone.com/epirus-expands-biosimilar-pipeline-and-capabilities-3/) - Cinfa Biotech S.L., the biosimilars company of Infarco group, today announced that the first subjects have been dosed in a clinical trial of B12019, a biosimilar version of Neulasta(R) (pegfilgrastim) to treat chemotherapy-induced neutropenia. B12019 is a pegylated granulocyte colony-stimulating factor (G-CSF) receptor agonist, which is used to stimulate bone marrow to produce more neutrophils
- [Cinfa Biotech treats first subjects in pegfilgrastim biosimilar clinical trial](https://medizone.com/epirus-expands-biosimilar-pipeline-and-capabilities-3/) - Cinfa Biotech S.L., the biosimilars company of Infarco group, today announced that the first subjects have been dosed in a clinical trial of B12019, a biosimilar version of Neulasta(R) (pegfilgrastim) to treat chemotherapy-induced neutropenia. B12019 is a pegylated granulocyte colony-stimulating factor (G-CSF) receptor agonist, which is used to stimulate bone marrow to produce more neutrophils
- [Intas launches Razumab, the first biosimilar to Lucentis](https://medizone.com/en/intas-launches-razumab-the-first-biosimilar-to-lucentis/) - Intas Pharmaceuticals has launched Razumab™, its biosimilar to Lucentis® (Ranibizumab). Intas is the first company globally to develop and launch a biosimilar version of Ranibizumab. Razumab is manufactured under strict guidelines for sterile use in the eye and is offered as single dose vial, thus reducing the risk of contamination during use. Ranibizumab is a
- [Intas launches Razumab, the first biosimilar to Lucentis](https://medizone.com/intas-launches-razumab-the-first-biosimilar-to-lucentis-2/) - Intas Pharmaceuticals has launched Razumab™, its biosimilar to Lucentis® (Ranibizumab). Intas is the first company globally to develop and launch a biosimilar version of Ranibizumab. Razumab is manufactured under strict guidelines for sterile use in the eye and is offered as single dose vial, thus reducing the risk of contamination during use. Ranibizumab is a
- [Ranbaxy launches first Biosimilar Infliximab in India!](https://medizone.com/en/ranbaxy-launches-first-biosimilar-infliximab-in-india/) - Ranbaxy Laboratories Limited (Ranbaxy), one of India’s largest pharmaceutical company, announced on 1.12.2014 the launch of Infimab (BOW015), the first Remicade (infliximab) biosimilar in India. Infimab, is being introduced in the Indian market through a licensing partnership with Epirus Biopharmaceuticals, Inc. a US and Swiss-based biopharmaceutical company focused on the global development and commercialization of
- [FDA Accepts Sandoz Application for Biosimilar Filgrastim](https://medizone.com/fda-accepts-sandoz-application-for-biosimilar-filgrastim-2/) - Sandoz, a Novartis Group company, has announced that FDA has accepted its Biologics Licence Application for filgrastim, which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The reference product — Amgen's Neupogen — is indicated to decrease the incidence of infection, as manifested by

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- [Privacy Policy](https://medizone.com/datenschutzerklaerung/) - Responsible i.S.d. Art. 4 Nr. 7 DSGVO: Medizone Germany GmbH, Keltenring 15, D-82041 Oberhaching - Munich - Phone: +49 89 12 11 26 36 - Data protection
- [Code of Conduct | COC](https://medizone.com/unternehmen/verhaltenskodex/) - Please click on the image below to read our Code of Conduct.
- [Verhaltenskodex | COC](https://medizone.com/unternehmen/verhaltenskodex/) - Bitte auf das Bild unten klicken, um unseren Verhaltenskodex (Code of conduct) zu lesen.
- [Kompetenzen](https://medizone.com/unternehmen/kompetenzen/) - Wir sind ein international tätiger pharmazeutischer Großhandel mit Sitz in Oberhaching bei München.
- [Partner](https://medizone.com/partner/) - To meet our high quality and safety standards in warehousing, transport and regulatory, we carefully choose our network of specialists.
- [Partner](https://medizone.com/partner/) - Unsere hohen Qualitäts- und Sicherheitsstandards, bei der Lagerhaltung und Transport, erreichen wir durch die sorgfältige Auswahl eines Netzwerks aus Spezialisten.
- [Vergleichspräparate für klinische Studien](https://medizone.com/service-2/vergleichspraparate-fur-klinische-studien/) - Comparator Sourcing - Mit unserer Expertise unterstützen wir Sie tatkräftig bei der Beschaffung der benötigten Vergleichspräparate für Ihre klinischen Studien.
- [Management - Medizone Germany](https://medizone.com/unternehmen/management/) - Global Pharma Sourcing - Gerhard Hörl - Managing Director, shareholder. Birgit Glaubitz - Managing Director, co-founder, shareholder - Medizone Germany
- [Mission](https://medizone.com/unternehmen/mission/) - Wir unterstützen führende Pharma-und Biopharma Unternehmen, bei der Entwicklung neuer Medikamente, in dem wir sie mit Mustern für die analytische Entwicklung und Vergleichspräparate für klinische Studien beliefern. Medizone Pharma Großhändler.
- [News](https://medizone.com/news/) - Welcome to our news section. We are a pharmaceutical wholesaler based in Munich with an international network of approved partners in the industry!
- [News](https://medizone.com/news/)
- [Kontaktformular](https://medizone.com/kontakt/kontaktformular/) - Medizone Germany GmbH - Keltenring 15 - 82041 Oberhaching Germany - Tel: 0049 89 12 11 26 36 - Fax: 0049 89 12 11 26 37
- [Management](https://medizone.com/unternehmen/management/) - Gerhard Hörl - Geschäftsführender Gesellschafter und Großhandelsbeauftragter. Birgit Glaubitz - Geschäftsführende Gesellschafterin. Medizone Germany GmbH
- [Service](/service/comparator-sourcing/) - Comparator sourcing partner for clinical trials and specialist for biosimilars - we focus on integrated customized solutions with the highest standard of quality.
- [Company](/company/competences/) - We are a pharmaceutical wholesaler - our focus is the supply of comparator products, analytical samples, unlicensed and emergency medicines.
- [Contact Form](https://medizone.com/kontakt/kontaktformular/) - Contact us: Medizone Germany GmbH, Keltenring 15, 82041 Oberhaching, Germany - Phone: 0049 89 12 11 26 36 - Fax: 0049 89 12 11 26 37 - info(at)medizone.com
- [Contact](/contact/contactform/)
- [Kontakt](/kontakt/kontaktformular)
- [Service](/service/vergleichspraparate-fur-klinische-studien)
- [Unternehmen](/unternehmen/kompetenzen)

## Slider

- [](https://medizone.com/?slider=global-pharma-sourcing)
- [Global Pharma Sourcing](https://medizone.com/?slider=global-pharma-sourcing)
- [Internationaler Pharmahandel](https://medizone.com/?slider=4) - Gerne unterstützen wir Großhändler, Importeure und Hilfsorganisationen, bei der Beschaffung von Arzneimitteln aus Deutschland und anderen europäischen Ländern.
- [Comparator Sourcing for clinical trials](https://medizone.com/?slider=comperator-sourcing-for-clinical-trials) - We source Comparator products from almost anywhere in the World and have direct access to many innovators and approved supply sources.
- [Unlicensed Medicines Supplies](https://medizone.com/?slider=headline-three) - We supply prescription only and OTC products to companies that have specialized in unlicensed medicines supplies, government agencies, hospitals and pharmacies.
- [Analytical Samples for Biosimilar Development](https://medizone.com/?slider=headline-two) - We supply analytical samples for Biosimilar development from almost anywhere in the world – Multi-country, Multi-batch and Multi-expiry date approach.
- [International Pharma Supplies](https://medizone.com/?slider=4) - We supply prescription only and OTC products to authorized wholesalers, licensed importers and aid organisations - from anywhere in the EU with a focus on German products.
- [Vergleichspräparate für klinische Studien](https://medizone.com/?slider=comperator-sourcing-for-clinical-trials) - Für Ihre Studie beschaffen wir die benötigten Vergleichspräparate, unter Einhaltung höchster Qualitätsansprüche und gemäß Ihren Vorgaben.
- [Einzelexporte – „Unlicensed Medicine“](https://medizone.com/?slider=headline-three) - Wir liefern weltweit lebenserhaltende Medikamente und andere dringend benötigte Arzneimittel.
- [Muster für analytische Entwicklung](https://medizone.com/?slider=headline-two) - Für die analytische Entwicklung beschaffen wir nach Ihren individuellen Anforderungen Muster mit unterschiedlichen Verfallsdaten, Chargen sowie aus unterschiedlichen Ursprungsländern.

## Kategorien

- [Allgemein](https://medizone.com/category/allgemein/)
- [News](https://medizone.com/category/news/)
- [Blog](https://medizone.com/category/blog/)
- [Comparator Sourcing](https://medizone.com/en/category/allgemein-2/)
- [@de](https://medizone.com/category/de/)
- [Comapartor Sourcing](https://medizone.com/category/comapartor-sourcing/)
- [Biosimilar Development](https://medizone.com/en/category/biosimilar-development/)
- [Unlicensed Medical Supplies](https://medizone.com/category/unlicensed-medical-supplies/)
- [Global Pharma Sourcing](https://medizone.com/category/global-pharma-sourcing/)
- [Unlicensed Medical Supplies](https://medizone.com/en/category/unlicensed-medical-supplies-2/)
- [Global Pharma Sourcing](https://medizone.com/en/category/global-pharma-sourcing-2/)
- [Vergleichspräparate für klinische Studien](https://medizone.com/category/vergleichspraeparate-fuer-klinische-studien/)
- [News](https://medizone.com/en/category/news-2/)
- [Blog](https://medizone.com/en/category/blog-2/)