Next generation and biosimilar monoclonal antibodies: Essential considerations towards regulatory acceptance in Europe; February 3-4, 2011; Freiburg, Germany

Abstract

The “Next Generation and Biosimilar Monoclonal Antibodies: Essential Considerations Towards Regulatory Acceptance in Europe” workshop, organized by the European Centre of Regulatory Affairs Freiburg (EUCRAF), was held February 3-4, 2011 in Freiburg, Germany. The workshop attracted over 100 attendees from 15 countries, including regulators from 11 agencies, who interacted over the course of the two days. The speakers presented their authoritative views on monoclonal antibodies (mAbs) as attractive targets for development, the experience to date with the regulatory process for biosimilar medicinal products, the European Medicines Agency draft guideline on biosimilar mAbs, as well as key elements in the development of mAbs. Participants engaged in many lively discussions, and much speculation, on the nature of the quality, non-clinical and clinical requirements for authorization of biosimilar mAbs.