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EU’s CHMP Expected To OK Another Biosimilar Humira

Executive Summary

The European Medicines Agency’s CHMP is expected to give the green light to Samsung Bioepis’ biosimilar version of AbbVie’s anti-TNF-alpha Humira on June 23. Numerous other biosimilar developers have biosimilar adalimumabs under development in a bid to break into the $16bn market for the world’s top-selling drug.

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Sandoz Files Biosimilar Humira & Remicade In EU; 13 Products Now Under Evaluation By CHMP

Applications for biosimilar medicines are continuing to arrive at the European Medicines Agency, with Sandoz’s versions of AbbVie’s Humira and Janssen’s Remicade having just been accepted for filing. This brings to 13 the number of biosimilars under evaluation; seven more are awaiting a marketing authorization decision from the European Commission.

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