EMEA workshop on Monoclonal Antibodies

• Date:
  donderdag, 2 juli 2009, Hele dag
• Locatie:
  European Medicines Agency, Amsterdam, the Netherlands

The EMEA workshop on biosimilar monoclonal antibodies (mAbs) was intended to discuss the feasibility of the scientific development and authorisation of monoclonal antibodies via the European biosimilar regulatory pathways. 159 people including health care professionals, academics, representatives from regulatory agencies in the European Union (EU), United States (US) and Canada, and 40 biopharmaceutical companies located worldwide attended the workshop. Participation was by invitation only.

Documents

Agenda - EMEA workshop on biosimilar monoclonal antibodies - Programme

Reference Number: EMEA/CHMP/BMWP/494490/2008

EMEA Workshop on the feasibility of Biosimilar monoclonal Antibodies - Welcome - Xavier Luria

Towards biosimilar monoclonal antibodies - Pros and cons - Christian K Schneider

Session 1 - CMC - Innovator Industry Presentation - Prof. Georg-B. Kresse

EGA-EBG's quality perspective on Biosimilar mAbs - Martin Schiestl

Session 1 - CMC - Kowid Ho

Session 2 - Non-Clinical Issues - Innovator Industry Presentation - Danuta Herzyk

EGA-EBG's Non-Clinical perspective on Biosimilar mAbs - Alexander Berghout

Regulator, Thinking - Non-clinical session - B. Silva Lima

Session 3 - Clinical Issues - Innovator Industry Presentation - Jay P. Siegel

Biosimilar mAbs - Clinical issues - Regulatory perspective - Christian K Schneider

Biosimilar mAbs - Outlook - Christian K Schneider