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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

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 EC’s marketing authorization of Imraldi, Samsung Bioepis becomes the industry’s first to European approvals for biosimilars referencing all three anti-TNF-alfa blockbusters. Benepali (etanercept) and Flixabi (infliximab) received EC marketing authorization in January 2016 and May 2016, respectively.

The EC approval of Imraldi applies to all 28 European Union (EU) member states as well as the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. Biogen will commercialize Imraldi in the EU and EEA member states.

The EC approval of Imraldi follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in June 2017.

Source: Biopharma News

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.

Medizone_expopharm

FDA rejects Coherus’ biosimilar application for Amgen’s 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 immunogenicity assay, and requests for certain additional manufacturing related process information. The FDA did not request a clinical study to be performed in oncology patients. Additionally, the CRL does not indicate additional process qualification lots would be required or raise concerns over the GMP status of CHS-1701 bulk manufacturing and fill-finish vendors.

Coherus states that, the company will work with the FDA to address the information requests.

“While we are disappointed in the delay that this additional request has caused, we remain confident in our ability to address the FDA’s requests for the purpose of obtaining approval for CHS-1701,” said Denny Lanfear, President and CEO of Coherus BioSciences.  

Source: Coherus BioSciences press release

Sandoz gains EU approval for biosimilar version of Roche’s 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 lymphocytic leukemia, as well as immunological diseases such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

The EC approval was based on a comprehensive development program generating analytical, preclinical, and clinical – including pharmacokinetic/pharmacodynamic (PK/PD) – data. The program demonstrated Rixathon matches its reference medicine in terms of safety, efficacy, and quality.

Source: Sandoz Press release

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