Europe to approve first biosimilars of Neulasta

  
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Europe’s first biosimilar alternatives to Amgen’s Neulasta (pegfilgrastim) neutropenia treatment are poised to enter the market after the European Medicines Agency (EMA) issued positive opinions for both Accord Healthcare’s Pelgraz and Coherus’ Udenyca 6mg solutions for injection. The European Commission typically decides on whether to convert the opinions into marketing authorisations within 67 days.

Europe’s first biosimilar alternatives to Amgen’s Neulasta (pegfilgrastim) neutropenia treatment are poised to enter the market after the European Medicines Agency (EMA) issued positive opinions for both Accord Healthcare’s Pelgraz and Coherus’ Udenyca 6mg solutions for injection. The European Commission typically decides on whether to convert the opinions into marketing authorisations within 67 days.

Accord’s vice-president of specialty brands, Paul Tredwell, told Generics bulletin that the Intas subsidiary is anticipating potentially being first-to-market with...

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