News and developments
Health Canada releases guidance on biosimilar biologic drug submissions
In May 2026, Health Canada published its Guidance on Information and Submission Requirements for Biosimilar Biologic Drugs. This guidance sets out the regulatory framework under which biosimilar sponsors may seek a Notice of Compliance (NOC) for a biosimilar biologic drug in Canada.
Key takeaways:
Biosimilars are not genericsHealth Canada's issuance of an NOC for a biosimilar is a confirmation of a high degree of similarity to the Canadian reference biologic drug, but is not a declaration of equivalence. Biosimilars, unlike generics, are not eligible for authorization through the Abbreviated New Drug Submission pathway due to their inherent heterogeneity and complexity, and submissions are instead filed using the New Drug Submission (NDS) pathway in accordance with section C.08.002 of the Food and Drug Regulations.Canadian reference biologic drugThe Canadian reference biologic drug serves as the foundation against which biosimilar sponsors must demonstrate high similarity. To qualify, the originator product must have been originally authorized based on a comprehensive quality, non-clinical and clinical data package and must possess a substantial body of evidence regarding quality, safety, efficacy, and effectiveness. An authorized biosimilar should not itself serve as a Canadian reference biologic drug for another biosimilar submission.Non-Canadian-sourced reference biologic drugSponsors may use a non-Canadian-sourced reference biologic drug as a proxy for the Canadian reference biologic drug in comparative studies, provided it has the same medicinal ingredients, dose, dosage form, frequency of dosage, and routes of administration as the Canadian reference biologic drug. The non-Canadian-sourced reference biologic drug should be marketed in a jurisdiction with regulatory standards and principles for evaluation of medicines, post-market surveillance activities, and approaches to comparability that are similar to Canada.Intellectual property considerationsIn a NDS, the biosimilar sponsor should clearly identify the biologic drug authorized in Canada to which it is subsequent. The sponsor should also identify the biologic drug to which it is making a direct or indirect comparison or reference according to the Patented Medicines (Notice of Compliance) Regulations ("PM(NOC) Regulations") and section C.08.004.1 of the Food and Drug Regulations.What biosimilar sponsors can rely onA biosimilar candidate leverages the safety and efficacy information of the Canadian reference biologic drug, benefiting from a reduced non-clinical and clinical package. Clinical studies are generally limited to a comparative pharmacokinetic trial demonstrating pharmacokinetic equivalence, with data on safety and immunogenicity also collected. Comparative clinical efficacy studies are not typically required when the biosimilar can be compared and extensively characterized by appropriate analytical studies. Differences between the biosimilar and the Canadian reference biologic drug may be acceptable if the sponsor demonstrates no impact on safety and efficacy; however, major differences can disqualify the product as a biosimilar.Extrapolation of indicationsAll indications granted to the Canadian reference biologic drug can be applied to the biosimilar candidate without further justification, provided the biosimilar has been shown to be highly similar to the Canadian reference biologic drug in terms of analytical characteristics and in functional properties related to the mechanism of action. A biosimilar may only be authorized for indications that are authorized for the Canadian reference biologic drug.Post-market obligations for biosimilar sponsorsBiosimilar sponsors must comply with adverse drug reaction ("ADR") reporting requirements, which must include the unique brand name, non-proprietary name, DIN, and lot number to facilitate traceability of adverse reactions to specific products.If you have questions or need assistance with navigating the drug regulatory framework in Canada, please contact DLA Piper’s Intellectual Property & Technology practice group.
