How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006

Posted 22 May 2012 By Hoss A. Dowlat

This is the first of a two-part series on the pre- and postapproval clinical safety of known EU-approved biosimilar therapeutic protein medicinal products. It compares and contrasts EU experience with the long-awaited, overarching FDA biosimilars guidances. It also anticipates the safety of as-yet-unapproved potential biosimilars, including the recombinant mAbs, insulins, heparins and interferons. Biosimilar medicinal development strategy, perception of general risk, interchangeability, substitution and other aspects of acute or chronic use and first/second line or adjunct therapy are addressed.

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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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