CMC Workshop: From Drug Development to Global Supply to Patients

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Session 7C: Biosimilars

Session Chair(s)

Gregory C. Davis, PhD

Consultant

Davis Consulting Services, United States

This session will examine the EU, Canada, and US regulatory pathways for the registration of biosimilars and discuss lessons learned from the implementation and application of these pathways to product reviews. The speakers will also update any anticipated changes to the pathways or to existing guidance.

Speaker(s)

EU Regulatory Update On Guidance And Experience With Biosimilars (Presentation will be given remotely via webinar)

Peter Richardson, PhD

European Medicines Agency, Netherlands

Head of Quality, Specialised Scientific Disciplines Department

Canadian Approach to the Regulation of Subsequent Entry Biologics (Biosimilars)

Anthony Ridgway, PhD

Health Canada, Canada

Acting Director, Biologics and Genetic Therapies Directorate

FDA Update on the Implementation of the Biosimilar Approval Pathway

Steven Kozlowski, MD

FDA, United States

Director, Office of Biotechnology Products, OPQ, CDER

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