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Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learnt and open questions based on 10 years experience of eu regulatory pathway

  • At: 2014 FIP Congress in PSWC, Melbourne (Australia)
  • Type: Presentation
  • By: CHAMBERLAIN, Paul (NDA Advisory Services Ltd, Board Member, Leatherhead, surrey, United Kingdom)
  • Abstract:

    learnt and open questions based on 10 years experience of EU regulatory pathway

    This presentation will review the way in which EU regulatory agencies have assessed the relative immunogenicity-related risks for different candidate biosimilar products since the inception of the EU biosimilar regulatory pathway in 2003. The following points will be..

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Last update 4 October 2019

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