Features

17 July 2012

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

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. [Read More...]

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22 May 2012

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

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. [Read More...]

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