Lupin’s Pegfilgrastim Biosimilar Accepted By US FDA
Neulasta Rival Faces A Crowded Market With Four Approved Competitors
Lupin’s first US biosimilar application, for a rival to Neulasta, has been accepted for filing by the FDA. If approved, the product would join an already crowded market for pegfilgrastim in the US.
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Amgen has been rebuked by the FDA over promotion for its unique Neulasta Onpro on-body injector version of pegfilgrastim, in which the firm made false or misleading claims about its benefit compared to a pre-filled syringe formulation of pegfilgrastim, where biosimilar competition exists.
Lupin has claimed a first with a UK approval for a rival to Fostair. The Indian company has told Generics Bulletin that it is planning to roll out the Luforbec branded generic later this year.
Pfizer has pressed on with the launch of a fourth biosimilar pegfilgrastim product, Nyvepria (pegfilgrastim-apgf), according to an investment bank. With Amgen continuing to hold more than 70% of the market, there is opportunity for Pfizer to capture significant market share.