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Session 8: Postmarketing Phase: Approval is Just the Beginning
Session Chair(s)
Charles Barr, MD, MPH
Chief Medical Officer, Adaptic Health, United States
Approval of a biosimilar is just the beginning. This session will address postmarketing opportunities and challenges, postmarket safety monitoring and risk management, and areas where life-cycle management of biosimilars can differ from original biologics. Among the topics to be explored: What changes will be needed to meet the opportunity for interchangeability? What happens when changes are made to the reference biologic? How do the considerations for new indications, additional dosage forms, and presentations, PREA requirements, labeling maintenance, and manufacturing changes differ when your product is a biosimilar rather than an original biologic?
Learning Objective :
Speaker(s)
Carlos Sattler, MD
VP, US Clinical Development and Medical Affairs, Sandoz Inc. (a Novartis Company), United States
Speaker
Mark J Cziraky, PHARMD
Vice President of Research, Anthem HealthCore, United States
Speaker