Presentations & Articles

Presentations are posted as they were originally presented. Duplication in whole or part of a presentation is not authorized without the express written consent of its author.

CANADA

Biosimilars Status Update: Current Regulatory Landscape, Legislative Proposals, and European Experience

European Generics Pressing for Global Agreement On Biosimilars
By: Adrian Howard
Gowling Lafleur Henderson LLP

The European Generic Medicines Association (EGA) is pressing governments to draft a global agreement regarding the approval process for biosimilar medicines (“follow-on biologics”). Addressing the 8th EGA International Symposium on Biosimilar Medicines in London, EGA Director General Greg Perry advocated that now is the time to seek an international guideline. With the first major group of originator’s biosimilar products coming off of patent and/or data protection, it is expected the market for biosimilars to greatly increase in the coming years.

Learn more and access links to recent releases and articles on the issue - European Generics Pressing for Global Agreement On Biosimilars

	Subsequent Entry Biologics: Are we ready? Presented by John Norman, Ph.D., Gowling Lafleur Henderson LLP and Philip Schwab, Ph.D., BIOTECanada Webinar - August 23, 2010

Content includes:

Examination of core issues and challenges to the emergence and adoption of SEBs, including regulatory issues, Canada's current guidance document, the use of reference products, and interchangeability
Current SEBs in the market globally
IP protection strategies for biologics including PM(NOC) procedure and infringement action
Case studies involving biologics

Click here to download the Subsequent-Entry Biologics in Canada presentation.

Click here to download the IP Protection Strategies for Biologics presentation.

Health Canada Aims to Finalize its Biosimilar Pathway Guidances
Presented by Adrienne Blanchard
Gowling Lafleur Henderson LLP

Content includes:

Intellectual property concerns
Interchangeability concerns
Product monography/labeling requirements
Potential use of foreign reference products

This article originally appeared in FDLI Update magazine's July/August 2009 issue and is reprinted with permission from the Food and Drug Law Institute

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An Update on Subsequent Entry Biologics
Presented by Adrienne Blanchard
Gowling Lafleur Henderson LLP

Content includes:

Health Canada's second-released draft guidance document
Proposed changes to Health Canada's guidances relating to the Patented Medicines (Notice of Compliance) Regulations and Data Protection Regulations.

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