Guidance document from Health Canada on biosimilar submission requirements

December 26, 2016 7:50 AM


Last month, Health Canada revised the guidance on Information and Submission Requirements for Biosimilar Biologic Drugs.

Health Canada, the federal regulatory authority that evaluates the safety, efficacy, and quality of drugs available in Canada, recognises that with the expiration of patents for biologic drugs, manufacturers may be interested in pursuing subsequent entry versions of these biologic drugs. The term biosimilar biologic drug, referred to as biosimilar, is used by Health Canada to describe subsequent entry versions of a Canadian approved innovator biologic with demonstrated similarity to a reference biologic drug.

Biosimilars were previously referred to as Subsequent Entry Biologics (SEBs) in Canada. With this new guidance, Health Canada, accepts to use the term “biosimilar” like FDA and other major agencies.

The English version of the updated guidance document can be found here.





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