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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