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Session 2: Switching and Interchangeability
Session Chair(s)
Hillel P Cohen, PhD
Executive Director, Scientific Affairs
Sandoz Inc., United States
Switching from reference biologics to biosimilars is now accepted as a safe and effective practice. But the licensure of multiple biosimilars to the same reference product has led to the possibility of switching from one biosimilar to another biosimilar. We will review published studies that describe such biosimilar to biosimilar switches. In addition, The recent approval of the first interchangeable insulin by the FDA has opened the possibility of having more interchangeable biosimilar products becoming available in the US market. We will examine how interchangeability was and is being pursued for select biosimilar insulins.
Learning Objective : At the conclusion of this session, participants should be able to:
- Discuss the current data supporting biosimilar-to-biosimilar switching
- Explain the rationale for interchangeability of biosimilar insulins
Speaker(s)
Biosimilar-to-Biosimilar Switching
Hillel P Cohen, PhD
Sandoz Inc., United States
Executive Director, Scientific Affairs
Interchangeability: From Insulins to mAB’s
Sundar Ramanan, PhD
Biocon Biologics, India
Vice President, Global Regulatory Affairs