Health Canada to modernize biologic drug submissions

Health Canada has made two announcements aimed at modernizing and streamlining submissions for biologic drugs, for both biosimilars and innovative biologic drugs. Stakeholders are encouraged to provide comments on the draft guidance to Health Canada until September 8, 2025.

What you need to know

• Health Canada has issued new industry guidance to support recent amendments to the Food and Drug Regulations, intended to streamline and modernize new drug submission requirements.
• A separate draft guidance relating to biosimilar submissions has also been published for consultation¹. If adopted, biosimilar manufacturers would not be required to conduct comparative clinical efficacy and safety trials in order for their product to be granted marketing authorization.
  • This change would reduce the development timeline for biosimilars, potentially accelerating the time to market.
  • Stakeholders are invited to comment on the draft guidance until September 8, 2025.

Modernizing and streamlining submission requirements for biologic drugs

New guidance applicable to all biologic drug submissions

In November 2024, Health Canada published amendments to the Food and Drug Regulations, including a new Division 4 directed specifically to biologic drugs². Health Canada introduced the new Division 4 Regulations (the new Regulations) to replace those originally dating back to the 1950s and 1960s, which Health Canada viewed as outdated, overly prescriptive and unnecessarily product-specific. Health Canada has stated that the new Regulations are intended to provide a flexible, outcome-based approach to the regulation of biologic drugs, including a modern approach to identifying submission requirements. The new Regulations came into force on July 1, 2025.

Despite the fact that Division 4 has been completely replaced, new guidance published by Health Canada clarifies that these new Regulations will not result in significant changes to submission requirements at this time. Health Canada’s new guidance is intended to help manufacturers with the transition of regulatory requirements under the old Division 4 Regulations to the new Division 4 Regulations, and to explain how the requirements of the old regulations track onto the new regulatory language.

Although the regulatory language has been updated to be less prescriptive, Health Canada has stressed that current practices will not be changing at this time. Rather, the new Regulations are designed to enshrine Health Canada’s current approach to biologic drug oversight in a modern regulatory framework. For example, previously Health Canada would occasionally require periodic quality reporting for certain drugs, which was applied using a discretionary and risk-based approach. This practice is now enshrined in the new Regulations, and specifically allows for increased flexibility in the ability of Health Canada to require periodic quality reporting and to prescribe any terms of that reporting.

Consultation on draft biosimilar guidance

Health Canada has also moved to modernize and streamline submission requirements for biosimilar drugs. Consistent with current Health Canada practice, the proposed submission requirements for biosimilar drugs are not set out in new regulations, but instead are found in a new proposed industry guidance document. Several changes have been proposed, and Health Canada has opened a consultation for stakeholders and other interested parties to submit comments until September 8, 2025.

Some of the proposed major changes to biosimilar submission requirements include:

• A focus on structural similarity. Throughout the proposed guidance, there is an emphasis on submissions demonstrating a “high degree of similarity” between the biosimilar and the Canadian reference biologic drug. The proposed guidance includes new sections on how biosimilar manufacturers may demonstrate similarity to either a Canadian reference biologic drug or to some other reference standard.
• A shift away from comparative clinical trials. The proposed guidance removes a previous statement on the importance of clinical efficacy or safety trials, focusing instead on comparative clinical pharmacology studies. There is also a shift in focus away from demonstrating an absence of clinical differences: instead, manufacturers must demonstrate a high degree of similarity between products, reflecting an overall emphasis on structural similarity as a key focus of biosimilar applications.
• Indications based on similarity alone. Currently, a “detailed rationale that scientifically justifies” a proposed indication must be provided alongside a biosimilar regulatory submission to Health Canada, and indications are reviewed and approved on a case-by-case basis. However, in the proposed guidance, this requirement has been eliminated in favour of indications being approved primarily based on demonstrating a “high degree of similarity” with the Canadian reference biologic drug.
• Reduced labelling requirements. The proposed guidance removes some of the label information currently required for biosimilar drugs, including a statement that indications are granted on the basis of similarity to a reference biologic drug, and the table showing comparative data on which the biosimilar approval is based.
• Risk management plan changes. The proposed guidance clarifies that a biosimilar risk management plan should be based on the risk management plan of the Canadian reference biologic drug, as well as on safety concerns which are unique to the biosimilar drug.

These proposed changes to the guidance reflect Health Canada statements in recent years which downplay the importance of clinical studies in supporting biosimilar applications. For instance, in a 2023 webinar hosted by the U.S. Food and Drug Administration (FDA), a Health Canada spokesperson emphasized that the requirement for comparative clinical efficacy studies could be waived if certain pharmacodynamic information is available, and that at the time, nine biosimilar drugs had been approved in Canada without clinical efficacy trial data³. The proposed changes appear to enshrine this approach as the new Canadian default.

It also appears that Health Canada’s changes to its biosimilar guidance mirror similar developments by the FDA (which has proposed guidance updates eliminating the need for biosimilar manufacturers to provide clinical switching studies)⁴ and the European Medicines Agency (which has published a new guidance document providing a pathway for biosimilars to be approved without comparative efficacy studies)⁵. Health Canada typically tries to move in step with its peer regulators where it feels that such regulatory changes would not compromise the health and safety of Canadians, and it appears such an approach is being taken with the draft biosimilar guidance it has published for consultation.

What’s next

Stakeholders are encouraged to provide comments on the draft guidance to Health Canada until September 8, 2025. The timeline for finalized guidelines is unknown at this stage.