Amneal Makes It Three With Pegfilgrastim Approval
Third US Biosimilar Fylnetra Follows FDA Nods For Filgrastim And Bevacizumab
Amneal has celebrated its third US biosimilar approval of 2022 with an FDA nod for its Fylnetra (pegfilgrastim-pbbk) rival to Neulasta, as the firm makes launch preparations for all three products across the second half of the year.
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At an eventful time for US biosimilars, a fresh wave of players entering the market is expected to both increase competition and broaden access, AmerisourceBergen’s senior vice president for global emerging therapies and channel strategy Beth McMahon tells Generics Bulletin.
Amneal has received approval for its second US biosimilar in the form of the mAbxience-developed Alymsys rival to Avastin. The product represents just the third biosimilar version of bevacizumab to be approved in the US.
With its Udenyca pegfilgrastim biosimilar sales plunging in 2021 amid pricing and volume pressures, Coherus is looking to balance price and share trade-offs in 2022 before the intended launch of its proposed on-body injector device next year – in turn aiming to become the eventual pegfilgrastim market leader.