Big Molecule Watch
April 20, 2022

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 (bevacizumab-awwb) in 2017.  ALYMSYS is a vascular endothelial growth factor inhibitor indicated for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma in adults, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Last month, Amneal received FDA approval of RELEUKO (filgrastim-ayow), a filgrastim biosimilar referencing NEUPOGEN.  Amneal’s pegfilgrastim biosimilar referencing NEULASTA is currently under review by the FDA.

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