Amneal announces U.S. FDA filing acceptance of biologics license application for bevacizumab

Amneal Pharmaceuticals

17 June 2021 - Bevacizumab represents the third biosimilar BLA currently filed by Amneal with the FDA.

Amneal Pharmaceuticals today announced the U.S. FDA has accepted for review the biologics license application for bevacizumab, pursuant to Section 351(k) pathway of the Public Health Service Act, and with a standard review goal date in the second quarter of 2022 according to the BsUFA (Biosimilar User Fee Act).

Read Amneal Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Medicine , US , Biosimilar , Dossier