Amneal Receives the US FDA’s Approval for Alymsys (biosimilar, bevacizumab)
- The US FDA has approved the BLA for bevacizumab-maly, a biosimilar referencing Roche’s Avastin for the treatment of mRCC, Stage III or IV ovarian cancer, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer and persistent, recurrent cervical cancer
- The approval marks the second approval for Amneal in 2022. Earlier, the company received approval for Releuko (filgrastim-ayow), a biosimilar referencing Neupogen
- Amneal expects the approval of a third biosimilar this year, a pegfilgrastim biosimilar referencing Amgen’s Neulasta, which is currently under FDA’s review
Ref: Amneal | Image: Businesswire
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