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Pfizer’s Pegfilgrastim Biosimilar ‘Has Launched’ In The US

FDA Approval In June 2020 Hung Up By IP Barriers

 
• By Dean Rudge

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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Pfizer has entered the race for market share in the mult-billion-dollar US pegfilgrastim market • Source: Shutterstock

Pfizer’s Nyvepria (pegfilgrastim-apgf) biosimilar is now available in the US, according to a leading investment bank, despite ongoing patent infringement litigation initiated by Neulasta (pegfilgrastim) sponsor Amgen.

Nyvepria was the fourth biosimilar Neulasta pre-filled syringe product approved by the US Food and Drug Administration in June last year, following the approvals across 2018 and 2019 for Viatris/Biocon’s Fulphila (pegfilgrastim-jmdb), Coherus

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