Canada · Health Canada · Biosimilars
Review target
300 days
performance goal
Legal time limit
-
Not published
Steps
3
9 requirements
Application fee
-
Canada has no separate law route for biosimilars. A biosimilar is filed and reviewed as a new drug submission, with data showing it is highly similar to a reference biologic authorized in Canada. Biologic drugs shown to be highly similar to a biologic already authorized in Canada.
The official review target is 300 days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. File the new drug submission; 2. Review (300 days); 3. Decision.
Outcome: Notice of compliance and DIN.
Legal basis: Food and Drug Regulations, Part C, Division 8 (section C.08.002)
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 300 days end to end with the official step targets. Targets, not actual times.
From the official approvals data of this market, all products of this pathway type and segment
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetperformance goal. Official target in calendar days for the agency's work. It is not an actual review time. Time the applicant takes to answer questions is not counted. The fee class for biosimilars was not confirmed. | 300 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Canada: New drug submission (new active substance), New drug submission or supplement (known substance), Priority review, Notice of compliance with conditions, Extraordinary use new drug submission, Public health emergency drug (rolling review), Ministerial reliance order (foreign decision deeming), Access Consortium work sharing, Project Orbis (cancer drugs), Special Access Program (drugs). See all routes on the Canada page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (14 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.