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Europe to approve first biosimilars of Neulasta

Executive Summary

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.

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