How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006 (Part 2)

Posted 17 July 2012 By Hoss A. Dowlat, PhD

This two-part series provides insights into the new paradigm of biosimilar medicines based on approval and medical experience postapproval. It proposes a framework for the understanding, development and acceptance of a new generation of biologic medicines, biosimilars, in the US and worldwide.

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Categories: Features, FDA, EMA

Tags: MAbs, Biogenerics, proteins, biosimilar, safety, Follow-on Biologics, Biologics, clinical trials, risk

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