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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recent biosimilar approvals as well as changes to the regulatory frameworks and guidances in these regions (e.g., FDA draft guidance on interchangeability).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)
Peter Richardson
Senior Quality Specialist, European Medicines Agency, Netherlands
Regulatory Update from Europe and IPRF Biosimilars Working
Juhong Liu, PHD
Scientist , FDA/CDER/OPQ/OBP/DBRRII , United States
Constructing a Comprehensive Analytical Similarity Assessment Program
Hans Joerg Toll
Head RegCMC Immunology Products, Sandoz Biopharmaceuticals, Austria
Biosimilar Development: Understanding Structure Function Relationships is Key
Patricia M. Seymour, MBA
Sr. Consultant, BioProcess Technology Consultants, Inc., United States
Case Study - CMC Challenges When a Small Biosimilar Developer Must Rely on Outsourcing for Development and Manufacturing Activities
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