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Current regulatory thinking on biosimilars

  • At: 2008 FIP Congress in Basel (Switzerland)
  • Type: Presentation
  • By: MORRIS, Tina S. (United States Pharmacopeia (USP), Rockville, United States of America)
  • Abstract:

    A clear regulatory picture for follow-on products has emerged in Europe, based on the concepts of similarity, comparability, and non-interchangeability. EMEA guidance clearly states that the standard generic approach is not scientifically appropriate for biologics and biotechnology-derived articles. Instead, the similarity approach is taken based

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Last update 4 October 2019

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