| Summary: | Health Canada, the national department responsible for regulating food, health and consumer products to keep Canadians safe, published the Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs on 14 November 2016 to update its framework for the market authorization of biosimilars in Canada. Biosimilars are the off-patent copies of biologics, a class of therapeutic agents derived from complex organic processing. Biosimilars are only “similar and not identical” to their reference biologic because biologics cannot be perfectly duplicated. As a result, biosimilars may not have the same safety profile as their reference biologic. As a number of biologics will be coming off patent in the coming years, Health Canada’s goal was to prepare by updating and clarifying the process surrounding market authorization.
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