Guidance on Biosimilar Submission Requirements in Canada

Health Canada, the federal regulatory authority that evaluates the safety, efficacy, and quality of drugs available in Canada recently released a revised Guidance Document on Information and Submission Requirements for Biosimilar Drugs (“Guidance”).  The Biologics and Genetic Therapies Directorate (BGTD) within the Health Products and Food Branch of Health Canada is the regulator of biologics drugs for human use and oversees the regulatory rules for biologics in Canada.

In conformity with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), the Canadian revised Guidance introduces the term “biosimilar biologic drug” or “biosimilar” which was previously referred to as “Subsequent Entry Biologics (SEBs)” in Canada.