Immunogenicity mitigation strategies for biosimilars

Tuesday 15th of April 2014
SY17, 1.5 hours

Chair: Paul Declerck (Belgium)

Meeting room 212 & 213

10.30 – 11.15  Multidisciplinary approach to evaluating immunogenicity of biosimilars: Lessons learnt and open questions based on 10 years experience of EU regulatory pathway
(TU-11-01) Paul Chamberlain, NDA Advisory Board, NDA Group, UK

11.15 – 12.00     Immunogenicity of Biosimilars: Considerations related to Evaluation Strategy and Challenges 
(TU-11-02) Freddy Faccin, Abbvie, USA