Amneal said the product, to be sold under the name Alymsys, is the second of 3 US biosimilars the company expects to see approved this year.
Amneal Pharmaceuticals Wednesday said the FDA approved the company’s Biologics License Application (BLA) for bevacizumab-maly, a biosimilar referencing the originator product (Avastin).
Amneal said the product will be sold under the name Alymsys. It is the third bevacizumab biosimilar approved in the United States, and the second of 3 US biosimilars the company expects to see approved this year.
Earlier this year, Amneal received approval of filgrastim-ayow (Releuko) which references Neupogen. The firm’s pegfilgrastim biosimilar referencing Neulasta is currently under FDA review.
Bevacizumab-maly was developed by mAbxience. The vascular endothelial growth factor inhibitor is indicated for the treatment of:
Avastin, made by Roche, brought in $7 billion for the company in 2018, according to Forbes.