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

  | Ref: BUSINESS WIRE | Image: Amneal