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Current regulatory thinking on biosimilars

  • In: S5 - Biosimilars (Part I): Dream to reality on Wednesday, 3 September 2008, 9:00-12:00
  • At: Basel (Switzerland) (2008)
  • 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 28 September 2023

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