Analysis of biosimilars: Finding the relevant needles in a haystack
- In: S5 - Biosimilars (part II): From science to practice on Wednesday, 3 September 2008, 14:00-17:00
- At: Basel (Switzerland) (2008)
- Type: Presentation
- By: VAN DE WEERT, Marco (University of Copenhagen, Copenhagen, Denmark)
Market approval of most generic medicines requires the generic manufacturer to show bioequivalence to the innovator drug. While a similar approach would be desired for biosimilar proteins, their highly complex behaviour makes this impossible. In particular, the danger of invoking an immune response is a special feature of protein drugs, and this.. 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.