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)
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.. The access to the whole abstract and if available the presentation file is available to FIP members and to congress participants of that specific congress.