Health Reform Observer - Observatoire des Réformes de Santé (Apr 2017)
Revising the Guidance Document for Biosimilar Agents
Abstract
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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