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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!

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 to us.

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 2018 – 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

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 granulocyte-colony stimulating factor (G-CSF) biosimilar in Europe. Once approved, Pelgraz could be the first pegfilgrastim biosimilar to market in Europe indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia for adult patients undergoing cytotoxic chemotherapy. The World Health Organisation consider G-CSF essential therapies due to their impact on febrile neutropenia, chemotherapy dose delays, and dose density.

Intas / Accord will manufacture Pelgraz in its own state of the art production facility. The company has deep experience with biosimilar medicines and as of 2017 were assessed as having the second highest number of biosimilars in phase III to approval in the world. This reflects the strategy of a long-standing commitment in biopharmaceutical development, research and manufacturing.

The CHMP positive opinion was based on Pelgraz’s substantial clinical development programme, which supported its biosimilarity with Neulasta through a Phase I, randomised, assessor-blinded PK/PD study in healthy volunteers, and a Phase III study of patients with breast cancer (stage IIa, IIb, or IIIa) on TAC (docetaxel, doxorubicin, cyclophosphamide).

Source: Intas Press release

FDA approves Mylan and Biocon’s 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) in patients treated with chemotherapy in certain types of cancer.

Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon’s joint portfolio approved in the U.S. Mylan anticipates launching Fulphila in the coming weeks, representing the first alternative, more affordable treatment option to Neulasta for oncology patients. A suite of patient services also will be available at launch to further support patients and caregivers with treatment.

Mylan has a portfolio of 20 biosimilar and insulin analog products and deep experience with more than 60 marketing authorizations for biosimilar products worldwide.

Mylan was the first company to receive FDA approval of Ogivri, a biosimilar to Herceptin (trastuzumab), in late 2017 and has continued to obtain regulatory approvals for biosimilar trastuzumab in nearly 30 additional countries around the world.

Source: Mylan press release

MSD launches Europe’s 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 licensed certain geographic rights to the biosimilar, as well as versions of other top-selling biologic drugs in Samsung Bioepis’ pipeline, in 2013.

Herceptin (trastuzumab) was Roche’s second-biggest product last year, bringing in more than CHF 7bn ($7.4bn). Ontruzant was approved by the EMA last November for the full range of registered indications for Herceptin, including early breast cancer, metastatic breast cancer and metastatic gastric cancer. Clinical trials of the drug showed it to be comparable to Herceptin in terms of structure, biological activity and efficacy, safety and immunogenicity profile, said MSD in a statement.

Ontruzant isn’t the only Herceptin biosimilar approved for marketing in Europe. Another South Korean firm – Celltrion – secured EMA backing for its Herzuma version of the drug last month. Both of these drugs are however copies of the older intravenous form of Herceptin, which is now used in only around half of Herceptin patients since Roche introduced a new subcutaneous formulation of the drug – which is easier and quicker to administer.

Ontruzant was the fourth biosimilar developed by the Korean company to receive marketing authorisation in the EU, after Benepali (etanercept), Flixabi (infliximab), and Imraldi (adalimumab).

Source: Biosimilar News

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 spinal cord injury. Since 2004, Wings for Life has funded life-changing research projects and clinical trials around the globe. While the cure is still to be found, steady progress has been made. One hundred percent of donations will help work toward Wings for Life’s ultimate goal.

www.wingsforlife.com

“It can happen to anyone of us. The question is not whether effective treatments and cures will be found, but when they will be found! We are proud to support Wings for Life!”

Gerhard Hoerl / MD Medizone Germany GmbH

Spinal cord injury must become curable!

WL

FDA approves Mylan and Biocon’s 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 or gastroesophageal junction adenocarcinoma).

Ogivri is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon’s joint portfolio approved in the U.S. Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin, as a result of Mylan’s ability to secure global licenses for its trastuzumab product from Genentech and Roche earlier this year. This milestone secured a clear pathway to commercialize Mylan’s biosimilar to Herceptin in various markets globally.

Mylan and Biocon’s biosimilar for Herceptin also is under review by regulatory authorities in Australia, Canada, Europe and several additional markets. It is already approved in 19 countries around the world, including India, thus providing increased access to this more affordable biologic for cancer patients.

Source: Biosimilar news

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 (EU) member states and the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. Ontruzant will be commercialized by MSD, which is known as Merck in the United States and Canada.

Ontruzant is the fourth biosimilar developed by Samsung Bioepis to receive EC marketing authorization. Samsung Bioepis has also received marketing authorizations for Benepali (etanercept), Flixabi (infliximab) and Imraldi (adalimumab).

Source: Samsung Bioepis press release

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