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Session 1 - Scientific Advances: The Concept of Biosimilarity
Session Chair(s)
Cecil J. Nick, MS
FTOPRA, Vice President (Technical)
Parexel Consulting, United Kingdom
Speaker(s)
Value of Physiochemical and Biological Data in Demonstrating Biosimilarity
Niklas Ekman
Finnish Medicines Agency, Finland
Senior Researcher
Quality Attributes for Monoclonal Antibody Biosimilars – How Much Difference is Acceptable?
Jerry D. Clewell, PharmD, MBA
Abbvie, United States
Assoc. Scientific Director, Global Med. Affairs Biologics Strategic Development
Meeting the Challenges of Demonstrating Biosimilarity at the Physicochemical and Biological Level
Jan Hillson, MD
Momenta Pharmaceuticals, Inc., United States
Senior Director of Clinical and Research
Value of Nonclinical and Clinical Data in Supporting Biosimilarity & Extrapolation
Joerg Windisch, PhD
Sandoz Biopharmaceuticals, Austria
Chief Science Officer
Q&A Panel Discussion (Session Speakers and)
Laurie Graham
FDA, United States
Director, DIPAP, OPPQ, OPQ, CDER
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