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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