Pharmaceuticals & Healthcare Analysis

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Industry Trend Analysis - EMA Approval Race Underway For Biosimilar Pegfilgrastim - APR 2018

Gedeon Richter is in a regulatory race with Sandoz (Novartis) for the first biosimilar pegfilgrastim product to be approved in the EU. However, both companies have suffered regulatory setbacks with their applications, highlighting the difficulties pegfilgrastim presents for biosimilar manufacturers. Gaining first-to-market status will be important for either firm, but Amgen's branded sales are...

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