Amneal Pharmaceuticals (AMRX) Granted Second US Biosimilars Approval with ALYMSYS

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Go back to Amneal Pharmaceuticals (AMRX) Granted Second US Biosimilars Approval with ALYMSYS

Amneal Achieves Second U.S. Biosimilars Approval with ALYMSYS® (bevacizumab-maly)

April 13, 2022 4:01 PM EDT

- Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (Amneal or the Company) today announced that the U.S. Food and Drug Administration (FDA) has approved the Companys 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, a global biotech company with over a decade of experience in the... More