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Amneal Launches FYLNETRA (pegfilgrastim-pbbk) in the United States

Big Molecule Watch

Last week, Amneal announced the launch of FYLNETRA (pegfilgrastim-pbbk), a biosimilar to Amgen’s NEULASTA, in the United States. Amneal developed FYLNETRA in collaboration with Kashiv Biosciences, a biopharmaceutical company located in Chicago, Illinois.

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The top 5 pharma M&A deals of 2020

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Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.

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Coherus Biosciences Announces Approval of a Pegfilgrastim Autoinjector

Big Molecule Watch

On March 6, 2023, Coherus Biosciences announced FDA approval of an autoinjectable version of Udenyca, Coherus’ biosimilar to Amgen’s Neulasta (pegfilgrastim). Udenyca (pegfilgrastim-cbqv) was first launched in the US in January 2019 and is one of six FDA approved pegfilgrastim biosimilars.

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Unpleasant truth: the pandemic, record debt and our opportunity for sustainability

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In my role at Sandoz, I work with teams that are passionately trying to drive healthcare sustainability through the increased use of high-quality biosimilars. 7 With a typical price difference between reference biologics and biosimilars in the range of -15% to -80%, the immediate potential budget impacts are in the tens of billions.

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EMA starts review of Enhertu for HER2+ gastric cancer

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Around one in five gastric cancers are HER2-positive, opening up a new market for AZ and Daiichi Sankyo, which have been collaborating on Enhertu since signing a multi-billion partnership for the drug in 2019. billion licensing deal.

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MacroGenics’ HER2 breast cancer drug Margenza approved in US

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Margenza (margetuximab) won FDA approval in combination with chemotherapy to treat metastatic HER2-positive breast cancer after at least two previous rounds of therapy. The median progression-free survival (PFS) of patients treated with Margenza and chemotherapy was 5.8 months in patients treated with trastuzumab and chemotherapy.

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Roche closes in on first-line use for lymphoma drug Polivy in Europe

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The CHMP backed Polivy (polatuzumab vedotin) for previously-untreated diffuse large B-cell lymphoma (DLBCL) in combination with R-CHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone) late last week.