Amneal Reports the US FDA’s Acceptance of BLA for Alymsys (biosimilar, bevacizumab)

Shots:

• The US FDA has accepted for review the BLA for bevacizumab, pursuant to section 351(k) pathway of the Public Health Service Act, and with anticipated BsUFA date in the Q2’22
• Amneal and mAbxience reported that data supports the bio similarity of its Alymsys to the reference, Avastin. The company expects its initial biosimilar portfolio will include Filgrastim (biosimilar for Neupogen), Pegfilgrastim (biosimilar for Neulasta) and Bevacizumab (biosimilar for Avastin)
• Bevacizumab represents the third biosimilar BLA currently filed by Amneal with the FDA. The EMA has approved Alymsys in Feb’21

Click here to­ read full press release/ article | Ref: BUSINESS WIRE | Image: Amneal