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IP Barriers Block Pfizer Following US Pegfilgrastim Approval

Sixth Oncology Biosimilar Approval Chalked Up

Executive Summary

Pfizer has won the first US Food and Drug Administration biosimilar approval this year, for its Nyvepria (pegfilgrastim-apgf) pre-filled syringes. However, it must overcome intellectual property hurdles before it can roll out the product.

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Pfizer Eyes EU Pegfilgrastim Roll-Out By 1 April As US Launch Is Confirmed

Pfizer will aim to have its biosimilar Neulasta (pegfilgrastim) product, Nyvepria, on the market in both the EU and US by the end of the current quarter, a company spokesperson has informed Generics Bulletin, following a successful US launch.

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

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.

Pfizer Picks Up EU Pegfilgrastim Approval

Pfizer has now received a formal European Commission approval for its Nyvepria biosimilar pegfilgrastim. The approval puts the firm in direct competition with several other versions of the Neulasta original.

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