Tagged as: Alymsys

Amneal Launches Bevacizumab Biosimilar in the United States

Yesterday, Amneal Pharmaceuticals, Inc. announced the launch of its first biosimilar in the United States:  ALYMSYS (bevacizumab-maly), a biosimilar referencing Genentech’s AVASTIN product.  ALYMSYS is a vascular endothelial growth factor inhibitor approved by the FDA in April 2022 for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent…

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FDA Approves Amneal’s ALYMSYS (bevacizumab-maly)

On April 13, 2022, Amneal Pharmaceuticals, Inc. announced that the FDA approved its BLA for bevacizumab-maly, a biosimilar of Roche’s AVASTIN.  The product will be marketed under the proprietary name ALYMSYS and represents the third bevacizumab biosimilar approved in the U.S, following Pfizer’s ZIRABEV (bevacizumab-bvzr) in 2019 and Amgen’s MVASI…

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CHMP adopts positive opinions on two bevacizumab biosimilars

At its January meeting last week, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval for two biosimilar bevacizumab medicines, Alymsys and Oyavas.  Mabxience Research SL’s Alymsys and STADA Arzneimittel AG’s Oyavas both received positive opinions for the treatment of carcinoma of the colon or rectum, breast cancer, non-small…

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