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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The US FDA conducted seven drug inspections in India from February through August 2021 and front-line Indian firms are hopeful things will pick up further and that some pre-approval inspections may happen virtually. But no foreign surveillance inspections are expected to be conducted by FDA inspectors traveling from the US before September 2021.
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.