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EMA ‘Yes’ For Pegfilgrastim Biosimilars Spells End For Neulasta’s EU Stronghold

 
• By Neena Brizmohun

Approval of the first pegfilgrastim biosimilars in the EU would mark the start of a period of accelerated sales declines for Amgen's Neulasta but the outlook for the blockbuster bio-originator is not necessarily bleak.

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Amgen's EU pegfilgrastim stronghold faces biosimilar attack • Source: Shutterstock

Coherus BioSciences and Accord Healthcare/Intas are set to become the first companies to break Amgen Inc.’s stronghold of the pegfilgrastim market in Europe.

The European Medicines Agency said today that it was recommending in favor of the European Commission approving biosimilar pegfilgrastim products made by both companies – Coherus’s product is

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