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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

  • In: SYMPOSIUM: IMMUNOGENICITY MITIGATION STRATEGIES FOR BIOSIMILARS on Tuesday, 15 April 2014, 10:30-12:00
  • At: PSWC, Melbourne (Australia) (2014)
  • 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 28 September 2023

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