‘Outstanding Issues’ Near For Products Approaching EU Review End – Including Neulasta Biosimilar

 
• By Maureen Kenny
  
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Ammtek, Pfizer, Portola and Roche are among the companies that are likely to find out what remaining concerns the European Medicines Agency’s key advisory panel, the CHMP, has regarding products of theirs that are nearing the end of the review pathway. Questions are likely to be in store for the sponsor of a biosimilar version of pegfilgrastim.

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It's a big week at the EMA • Source: Shutterstock

A number of companies whose products are at the later stages of evaluation at the European Medicines Agency will find out this week whether the agency has remaining concerns with their marketing authorization applications (MAAs). The products include a biosimilar version of Amgen’s blockbuster neutropenia drug, Neulasta (pegfilgrastim). Competition is fierce to be the first Neulasta biosimilar in Europe; six versions are currently under review at the EMA’s Committee for Medicinal Products for Human Use (CHMP).

One of the many things the CHMP does at its monthly meetings with regard to products that are under review...

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