On June 10, 2025, Health Canada initiated a public consultation on proposed revisions to its Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. A notable update is the proposal to remove the requirement for comparative clinical efficacy and safety trials for biosimilars in Canada.
Background: Regulatory Context in Canada
In Canada, biosimilar biologic drugs (“biosimilars”) are biologic drugs demonstrated to be highly similar to an already authorized biologic product termed the Canadian Reference Biologic Drug (“CRBD”). The Biologic and Radiopharmaceutical Drugs D (“BRDD”) within the Health Products and Food Branch of Health Canada is the regulator of biologic drugs for human use and provides regulatory oversight for biologics with its comprehensive reviews of biologic drug submissions covering quality, safety and efficacy.
Biosimilars are regulated under the Food and Drugs Act and Part C of the Food and Drug Regulations (“FDR”). Unlike generic drugs, biologics are complex and variable, so biosimilars are not considered pharmaceutically equivalent and cannot use the Abbreviated New Drug Submission (“ANDS”) pathway. Instead, they follow the New Drug Submission (“NDS”) pathway under section C.08.002 of the FDR.
Upon approval, Health Canada issues a Notice of Compliance (“NOC”) confirming the biosimilar's high degree of similarity to the CRBD in terms of structure, function, safety, and efficacy. However, this is not a declaration of equivalence. Biosimilar sponsors may request authorization for all indications held by the CRBD, provided adequate scientific justification is presented.
Proposed Change: Comparative Clinical Trials
Under the revised 2025 draft guidance, comparative clinical trials are no longer expected for biosimilar submissions. In most cases, a comparative clinical efficacy and safety trial(s) is not required. Safety and comparative immunogenicity data are still required and should be collected within the comparative clinical pharmacology studies but could be supplemented with data collected using other trial designs (e.g., studies designed to specifically focus on safety and/or immunogenicity). If a comparative clinical efficacy and safety trial(s) is deemed necessary, sponsors should provide a rationale to explain the purpose of the trial(s) in the context of a biosimilar submission.
Under the revised draft guidance, sponsors must provide:
- Comparative Pharmacokinetic (PK) studies;
- Pharmacodynamic (PD) studies, where feasible; and
- Comparative Immunogenicity testing and data, typically gathered during PK/PD studies.
Comparative clinical trials would only be necessary in exceptional cases, such as when analytical and clinical pharmacology data leave unresolved questions about biosimilarity. In such instances, sponsors must clearly justify the purpose of the trial(s) within the biosimilar development context.
Consultation Period and Stakeholder Input
The public consultation on the draft guidance has been ongoing since June 10, 2025, and will remain open until September 8, 2025. Health Canada is actively seeking feedback from a wide range of stakeholders, including:
- Industry sponsors and regulatory professionals;
- Clinicians and scientific experts;
- Academic researchers;
- Health system partners; and
- Patients and the general public.
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