Canadian Biosimilars Guideline

August 12, 2011 2:09 PM

Health Canada is the authority that oversees all drug registration activities in Canada.

Health Canada is the Federal department responsible for helping Canadians maintain and improve their health, while respecting individual choices and circumstances.

Biological drugs in Canada are regulated by the Biologics and Genetic Therapies Directorate (BGTD) of Health Canada (HC). HC uses the term “subsequent entry biologics (SEBs)” for biosimilars; they have initiated a biosimilars regulatory development process in the late 1990’s.

Sandoz’s Omnitrope was approved in April 2009 as the first biosimilar approved in Canada, before the regulation came into place.

Health Canada released their guideline, Guidance For Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs) in March 2010.

The guideline can be accessed from here.


UPDATE: In 2014, two biosimilars (subsequent entry biologics) got their approvals from Health Canada. These two products are the first ones to receive the approval via Health Canada’s SEB Guideline. Hospira’s Inflectra and Celltrion’s Remsima are both biosimilars of Remicade (infliximab).

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