Amneal Scores Second US Biosimilars Approval With Alymsys In Oncology

The FDA approved Amneal Pharmaceuticals Inc AMRX Biologics License Application (BLA) for bevacizumab-maly, a biosimilar referencing Avastin.

• The product will be marketed under the proprietary name Alymsys and represents the third bevacizumab biosimilar approved in the U.S.
• Alymsys was developed by mAbxience.
• Bevacizumab-maly is a vascular endothelial growth factor inhibitor indicated for various oncology indications. 
• The approval marks the second of three biosimilars approvals Amneal expects to receive this year in oncology. 
• Earlier this year, Amneal received approval for Releuko (filgrastim-ayow), a filgrastim biosimilar referencing Neupogen, and the company's pegfilgrastim biosimilar referencing Neulasta is currently under review by the FDA.
• According to IQVIA, U.S. annual sales for bevacizumab for the 12 months ended February 2022 were $2.6 billion, $1.6 billion of which represented biosimilar sales.
• Price Action: AMRX shares closed 1.96% lower at $4.25 during after-hours trading on Wednesday.