Analysis of biosimilars: Finding the relevant needles in a haystack
- At: 2008 FIP Congress in Basel (Switzerland)
- 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 the presentation file is available to FIP members and to congress participants of that specific congress.