Pfizer’s Pegfilgrastim Biosimilar ‘Has Launched’ In The US
FDA Approval In June 2020 Hung Up By IP Barriers
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.
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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.
Pfizer’s Nyvepria biosimilar was the fourth pegfilgrastim biosimilar approved by the FDA, despite ongoing litigation from originator Amgen. The biosimilar sponsor has cleared any niggling legal issues by settling litigation over a US patent directed at methods of protein purification.
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.