FDA Okays Third Biosimilar of Avastin

Amneal's Alymsys is approved to treat several cancers.

The FDA has approved Amneal Pharmaceuticals’ biologics license application (BLA) for bevacizumab-maly, a biosimilar referencing Genentech’s Avastin. The product will be marketed under the name Alymsys.

Alymsys is a vascular endothelial growth factor inhibitor used in oncology. It is approved to treat metastatic colorectal cancer, non-squamous small cell lung cancer, recurrent gliobastoma, renal cell carcinoma, recurrent or metastatic cervical cancer, and epithelial ovarian cancer.

“Biosimilars represent the next wave of affordable medicines in the U.S. and are closely aligned with our strategy to provide high quality, affordable medicines to as many patients as possible,” Chirag and Chintu Patel, co-chief executive officers,” said in a press release.

Alymsys was developed in collaboration with mAbxience. This marks the second of three biosimilars approvals Amneal expects to receive this year in oncology. Alymsys was approved by the European Medicines Agency (EMA) in February 2021.

Earlier this year, Amneal received approval of Releuko (filgrastim-ayow), a filgrastim biosimilar referencing Neupogen. Ameal’s pegfilgrastim biosimilar referencing Neulasta is currently under review by the FDA.

Related: FDA Okays a Third Biosimilar to Neupogen

Two other Avastin biosimilars have been approved, including Amgen’s Mvasi (bevacizumab-awwb), which was approved in September 2017, and Pfizer’s Zirabev (bevacizumab-bvzr), which was approved in June 2019.