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Session 7B: Biosimilars
Session Chair(s)
Anthony Ridgway, PhD
Acting Director, Biologics and Genetic Therapies Directorate
Health Canada, Canada
The development of biosimilars is continuing at a fast pace. This session will provide regulatory updates from the US and EU covering recent biosimilar approvals as well as changes to the regulatory frameworks and guidances in these regions (e.g., FDA draft guidance on interchangeability). Perspectives from industry speakers will include case studies illustrating obstacles for biosimilars in the CMC area and how these might be circumvented. During the panel discussion, CMC regulatory considerations for global development and the potential for a global regulatory submission will be explored.
Speaker(s)
Regulatory Update from Europe and IPRF Biosimilars Working
Peter Richardson, PhD
European Medicines Agency, Netherlands
Head of Quality, Specialised Scientific Disciplines Department
Constructing a Comprehensive Analytical Similarity Assessment Program
Juhong Liu, PhD
FDA/CDER/OPQ/OBP/DBRRII , United States
Scientist
Biosimilar Development: Understanding Structure Function Relationships is Key
Hans Joerg Toll
Sandoz Biopharmaceuticals, Austria
Head RegCMC Immunology Products
Case Study - CMC Challenges When a Small Biosimilar Developer Must Rely on Outsourcing for Development and Manufacturing Activities
Patricia M. Seymour, MBA
BioProcess Technology Consultants, Inc., United States
Sr. Consultant
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