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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)
  • Abstract:

    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

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Last update 4 October 2019

FIP Congresses