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Ottawa Marriott Hotel

Oct 28, 2014 8:00 AM - Oct 29, 2014 3:00 PM

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

DIA’s Annual Canadian Meeting: Thinking Globally, Acting Locally for The Well-Being of the Patient

Session 6 - Track A: Subsequent Entry Biologics/Biosimilars

Session Chair(s)

Andrew  Storey

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)

Agnes  Klein, MD

Biosimilars in Canada: Does the Process Differ From Other Countries?

Agnes Klein, MD

Health Canada, Canada

Senior Medical Advisor

Keith  Watson, PhD

Extrapolation, Naming and Consistency

Keith Watson, PhD

AbbVie Ltd, United Kingdom

Director, Global Regulatory Affairs, Biologics Strategic Development

Allison  Guy, MSc, RAC

Navigating the Marketing Application Process for Subsequent Entry Biologics

Allison Guy, MSc, RAC

Roche, Canada

Associate Director Regulatory Affairs

Christopher  Shanne

Navigating the Marketing Application Process for Subsequent Entry Biologics

Christopher Shanne

PAREXEL International, United States

Sr. Consultant

Brendan  McIntosh

Common Drug Review Process for Reviewing Subsequent Entry Biologics

Brendan McIntosh

CADTH, Canada

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