Biosimilars Conference

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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 :
Identify approaches to meeting the opportunities and challenges at the postmarketing phase of a biosimilar
Compare and contrast the life cycle management of a biosimilar with that of an original biologic

Speaker(s)

Speaker

Carlos Sattler, MD

Sandoz Inc. (a Novartis Company), United States

VP, US Clinical Development and Medical Affairs

Speaker

Mark J Cziraky, PharmD

Anthem HealthCore, United States

Vice President of Research

Biosimilars Conference

Session 8: Postmarketing Phase: Approval is Just the Beginning

Session Chair(s)

Charles Barr, MD, MPH

Learning Objective : Identify approaches to meeting the opportunities and challenges at the postmarketing phase of a biosimilar Compare and contrast the life cycle management of a biosimilar with that of an original biologic

Speaker(s)

Speaker

Speaker

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Learning Objective :
Identify approaches to meeting the opportunities and challenges at the postmarketing phase of a biosimilar
Compare and contrast the life cycle management of a biosimilar with that of an original biologic