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Speakers

The meeting provided insight into why monoclonal antibodies were attractive targets for development and what the key elements in development of a monoclonal antibody were. All speakers of the workshop are experts in the field and were involved in the development of monoclonal antibodies or biosimilar products or in the assessment of related regulatory submissions.

Gabriele Schäffner-Dallmann, EUCRAF/Pharmatching GmbH and Michael Reth, Max-Planck-Institut for Immunology Freiburg, provided a historic review and future prospects of monoclonal antibodies in Europe. Christian Schneider, PEI, Germany, discussed what was special with monoclonal antibodies. Ann Johnsson, MPA, Sweden, reviewed the experience on already authorized biosimilars and the approaches taken to justify biosimilarity. Thomas Kirchlechner, Sandoz, reflected the experience and challenges in development of biosimilars. Christian Schneider gave an update on the status of the guideline on biosimilar monoclonal antibodies and Martina Weise, BfArM, Germany, gave an update on the relevant WHO guideline.

Kowid Ho, AFSSAPS, France, presented the attempts being considered acceptable for a biosimilar monoclonal antibody, whether it had to be an identical copy or whether an altered manufacturing process might be acceptable. Martin van der Plas, RIVM, The Netherlands, discussed the CMC requirements and what could be characterized well, where were the limitations and what was special for introduction of changes in next generation vs biosimilar monoclonal antibodies. Karen de Smet, FAMHP, Belgium, gave an introduction into the requirements of preclinical development, what were the challenges in development of a new monoclonal antibody and what need to be considered for next generation and biosimilar monoclonal antibodies.

Frank Scappaticci, Roche/Genentech Inc., UK discussed the challenges in the development of a new monoclonal antibody and what needed to be considered for next generation and biosimilar monoclonal antibodies. For the clinical development, Jan Müller-Berghaus, PEI , Germany, discussed the key elements of clinical evidence – Key points to consider with regard to Surrogate endpoints - Immunogenicity – Extrapolation.

Participants could get a further insight into the current state of the art considerations during the panel discussions with representatives of agencies and industry and a networking dinner offers excellent opportunities to further exchange your views on the matter.