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)
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.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.