Sandoz Sanguine On Market Opportunity Despite Biosimilar Neulasta Setback

 
• By Lucie Ellis-Taitt
  
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Questions from European regulators around Sandoz's market application for biosimilar pegfilgrastim have prompted the company to withdraw the drug's filing – a delay which could allow competitor biosimilar developers to launch ahead of the Novartis-owned company.

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Sandoz withdraws European marketing application for biosimilar pegfilgrastim • Source: Shutterstock

Delays for Sandoz International GMBH could give competitors with rival biosimilar versions of Amgen Inc.'s Neulasta (pegfilgrastim) an opportunity to steal a march. Regulators have queried the Novartis AG-owned generics company's biosimilar pegfilgrastim filing in Europe, prompting it to withdraw its marketing application for the drug as a treatment for neutropenia.

The European Medicines Agency's scientific committee, the committee for medicinal products for human use (CHMP), said data provided by Sandoz...

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