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First Biosimilar Neulasta In Final Stages Of EMA Review Process

 
• By Ian Schofield

A biosimilar version of Amgen’s Neulasta has yet to be approved in the EU but one such product is in the later stages of review at the European Medicines Agency.

Review
Six biosimilar pegfilgrastims are under review at the EMA.

One of the six biosimilar versions of Amgen Inc.’s Neulasta (pegfilgrastim) that are under review at the European Medicines Agency has reached the later stages of the review process, with a “Day 180 List of Outstanding Issues” (LoOI) relating to the product being adopted at the December meeting of the CHMP, the agency’s main scientific committee.

As of Dec. 4, the EMA had a total of 15 biosimilar medicines under review. The pegfilgrastim products are arguably...

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