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Session 6 - Track A: Subsequent Entry Biologics/Biosimilars
Session Chair(s)
Andrew Storey
Vice President, Regulatory Affairs United States and Canada
AbbVie, United States
With the expiration of numerous patents for originator biologicals and the development of follow-on products, the market for biosimilars is growing at a rapid pace. These biosimilars and follow-on biologics have garnered interest for their cost-effective benefits in patient care but questions remain about many aspects of “similarity." As biosimilars become more available to patients, there are important factors for patients and health care providers that must be addressed. This session will focus on the innovations, technologies, and regulatory information surrounding biosimilars
Topics to be covered include Canadian and US Regulatory Developments, Interchangeability, Labeling, Naming, and Extrapolation and will be reviewed from various perspectives.
Speaker(s)
Biosimilars in Canada: Does the Process Differ From Other Countries?
Agnes Klein, MD
Health Canada, Canada
Senior Medical Advisor
Extrapolation, Naming and Consistency
Keith Watson, PhD
AbbVie Ltd, United Kingdom
Director, Global Regulatory Affairs, Biologics Strategic Development
Navigating the Marketing Application Process for Subsequent Entry Biologics
Allison Guy, MSc, RAC
Roche, Canada
Associate Director Regulatory Affairs
Navigating the Marketing Application Process for Subsequent Entry Biologics
Christopher Shanne
PAREXEL International, United States
Sr. Consultant
Common Drug Review Process for Reviewing Subsequent Entry Biologics
Brendan McIntosh
CADTH, Canada
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