The FDA approved Amneal Pharmaceuticals Inc (NYSE: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.
