New Biosimilar Guidance Document: Simplifying process for biosimilars
On May 19, 2026, Health Canada published a revised Guidance on Information and Submission Requirements for Biosimilar Biologic Drugs. Health Canada also published a summary of key changes. The guidance document provides information to assist sponsors in meeting the requirements for biosimilar drug submissions.
Biosimilar drug submissions are regulated under C.08.002 of the Food and Drug Regulations (FDR). The requirements set out in C.08.002(2)(g) and (h) can be satisfied by establishing a high degree of similarity to a Canadian Reference Biologic Drug (CRBD) through quality, clinical and non-clinical analyses. The revised guidance should make it easier for biosimilars to be approved by Health Canada.
Key updates to the guidance are explained here.
- Definition of “highly similar” added (s. 8.2): Highly similar was defined as: “A determination, based on robust and appropriately designed comparative analytical studies, that the proposed biosimilar and the reference biologic drug demonstrate analytical concordance in structural and functional characteristics, with critical quality attributes falling within prospectively justified, pre-defined ranges informed by CRBD variability, and that any observed differences have been assessed and determined not to have a meaningful impact on safety or efficacy.”
- Requirement for comparative clinical efficacy studies was modified (s. 5.3.2): The guidance removed the requirement for biosimilar sponsors to conduct comparative clinical efficacy and safety trials when the biosimilar can be compared and extensively characterized through analytical and clinical pharmacology studies.
- Requirement for scientific rationale for each indication removed (s. 6.1): The guidance removed the requirement for a detailed scientific rationale to justify authorization of the biosimilar for each indication. All the indications granted to the CRBD can be applied to the biosimilar candidate if the biosimilar candidate has been shown to be highly similar:
- to the brand product in terms of analytical characteristics; and
- in functional properties related to the mechanism of action of the CRBD.
- Section on quality information requirements expanded (s. 4): Quality sections were expanded to emphasize:
- quality data must be robust and comprehensive to support the establishment of a high degree of similarity;
- structural and functional studies are generally considered more sensitive than clinical studies for detecting differences between a biosimilar candidate and the CRBD; and
- comprehensive characterization is the primary driver for establishing similarity.
The guidance further explained the key types of data that sponsors are expected to submit to demonstrate similarity:
- Physicochemical Characteristics: Testing should include a determination of the composition, physical properties, and primary structure of the desired product. The molecular heterogeneity of the biosimilar candidate should also be considered.
- Purity and Impurities: Testing should allow for evaluation of relevant differences in purity and product-related impurity profiles, and the differences’ potential impact on safety and efficacy should be assessed.
- Functional Properties: Multiple functional assays should be performed as part of the similarity assessment, reflecting the mechanism(s) of action to the extent possible.
- Stability: Comparative stability studies (e.g., accelerated, stressed, and forced degradation studies) should be conducted to compare degradation profiles.
- Sections on clinical and non-clinical information requirements consolidated (s. 5): The guidance consolidated requirements that were previously set out under subsections for pharmacokinetic and pharmacodynamic studies, as well as safety and immunogenicity. It emphasized that the role of clinical studies is to support the demonstration of similarity derived from comparative analytical assessments. Clinical studies should primarily include a comparative pharmacokinetic study, and if feasible, may include a comparative evaluation of pharmacodynamics.
- Information for addressing immunogenicity added (ss. 4.3.2.3 and 5.3.1.1): The guidance provided additional information on immunogenicity in the quality and clinical data requirement sections. New subsections emphasize the shift toward using analytical and functional data to demonstrate comparable immunogenicity.
- Clarifications added regarding the scope of a biologic drug (s. 1.2) The guidance clarified that low molecular weight heparins (LMWHs) are regulated as biologic drugs due to their biologic origin, despite not being listed on Schedule D of the Food and Drugs Act. Short polypeptide drugs may be also regulated as biologic drugs if manufactured using recombinant DNA procedures
