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Biosimilars Law Blog

Category Archives: Biosimilar Definitions

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Posted in Biosimilar Definitions, Global Comparisons

EMA releases a draft revision to the Biosimilars Guideline for public consultation

The European Medicines Agency (“EMA”) initiated a public consultation on a proposed revision of its Guideline on “Similar Biological Medicinal Products” (the “Biosimilars Guideline”), available at the EMA website . The 2 April 2013 proposed revision would ultimately result in a new guideline replacing the current Biosimilars Guideline adopted in October 2005.