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

FDA Approval In June 2020 Hung Up By IP Barriers

Executive Summary

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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Amgen Pulled Up Over Anti-Biosimilar Pegfilgrastim Promotion

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’s Pegfilgrastim Biosimilar Accepted By US FDA

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.

Amgen’s Mvasi Set For Blockbuster Status With 50% Share In US

Amgen’s biosimilars sales will almost certainly smash through the $2bn barrier in 2021, driven by the strength of its product portfolio including bevacizumab and trastuzumab. The California-based biotech has warned, however, that greater competition will naturally lead to pricing challenges.

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