Around the world, health authorities and regulators are addressing ways to appropriately manage the approval of subsequent entry biologics (SEBs), also known as biosimilars.

While colloquially some have referred to these products as ‘generic biologics’, SEBs are larger molecules than chemical generic products and therefore cannot be considered to be true ‘generics’ that can be approved without clinical trials. As a result, regulators must create novel pathways and rules to govern the approval of these new health products.

With the March 2010 release of Health Canada’s Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs), Canadian health authorities have published their framework for the marketing approval of biosimilars. Yet, the first biosimilar was approved in advance of final Guidance with the approval of Sandoz Canada’s OMNITROPE product in April 2009. Health Canada is of the view that it has existing authority, under current Food and Drug Regulations, to approve biosimilars based on a reduced package of data than was submitted for the similar, innovative product, without the need for new regulations.

As Canada’s leading business law firm for the pharma and biopharma industry, Gowlings Life Sciences Group delivers unparalleled insight into the regulatory, legislative and IP issues that are driving this developing and complex medical field. We are a proud platinum supporter of BIOTECanada, Canada's national biotechnology industry organization, and a trusted partner to many of the world’s leading innovators in biotech, pharmaceuticals and life sciences.

We are pleased to provide this comprehensive resource for understanding the various guidance documents, regulations and industry positions related to SEBs in Canada, the US, the EU and other jurisdictions around the world.

We will continue to update this portal to provide new information as it becomes available, and to add to the library of reference documents related to biosimilars that can be found on our site.

For further information, please contact:

Vice Chair, Life Sciences Industry Group Adrienne M. Blanchard Tel: (613) 786-0223 Fax: (613) 788-3510 adrienne.blanchard@gowlings.com

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