This article provides an update on developments in the biosimilar space in Canada—regulatory, approvals, pending submissions, litigation, and market access—since our March 2024 update.
Regulatory
Consultation on revised biosimilar guidance: removal of comparative clinical efficacy and safety trial requirements: On June 10, 2025, Health Canada launched a consultation on proposed revisions to its draft Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. The most notable revision eliminates the requirement that biosimilar submissions include comparative clinical efficacy trials in most cases. The consultation is open until September 8, 2025.
Modernizing requirements for biologics: In November 2024, the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) were registered. On July 1, 2025, the portions replacing Part C, Division 4 for Schedule D Drugs—which includes all biosimilars—of the Food and Drug Regulations come into force. These changes remove outdated product-specific requirements that were not scientifically relevant and introduce broader, more flexible regulations that reflect current guidance and practice.
Biosimilars approved in Canada
Health Canada has approved ten biosimilars since our last update:
- Nora Pharma’s NIOPEG and JAMP Pharma’s FILRA, biosimilars of Amgen’s NEUPOGEN (filgrastim).
- Celltrion’s STEQEYMA, Samsung Bioepis’s PYZCHIVA, and Fresenius Kabi’s OTULFI, biosimilars of Janssen’s STELARA (ustekinumab).
- Lupin Pharma’s ARMLUPEG and JAMP Pharma’s PEXEGRA, biosimilars of Amgen’s NEULASTA (pegfilgrastim).
- Accord Healthcare’s ADHEROZA, biosimilar of Hoffmann-La Roche’s HERCEPTIN (trastuzumab).
- Fresenius Kabi’s TYENNE, biosimilar of Hoffmann-La Roche’s ACTEMRA (tocilizumab).
- Celltrion’s OMLYCLO, biosimilar of Novartis’ XOLAIR (omalizumab).
There are now 66 biosimilars approved in Canada of 20 innovator reference products, an increase of two innovator reference products since our last update, with the first approvals of omalizumab and tocilizumab biosimilars.
Our complete list of biosimilars approved in Canada is regularly updated.
Biosimilar submissions under review
Health Canada provides a monthly update of new drug submissions under review (SUR). Since October 2018, the SUR has identified the sponsor, the filing date, and the submission class of the submission, including whether it is a biosimilar. The most recent SUR (as of June 25, 2025) identifies the following biosimilar submissions under review, which includes submissions on IP hold:
- Aflibercept (seven separate submissions)
- Denosumab (eleven separate submissions)
- Eculizumab (three separate submissions)
- Natalizumab
- Pegfilgrastim
- Pertuzumab
- Rituximab
- Tocilizumab (two separate submissions)
- Ustekinumab (two separate submissions)
There continue to be three additional new drug submissions pending for trastuzumab, which are likely for biosimilars, but are not specifically identified as such as they were filed prior to October 2018.
Additionally, abbreviated new drug submissions remain under review by Health Canada for liraglutide (Novo Nordisk’s VICTOZA, SAXENDA, XULTOPHY) and semaglutide (Novo Nordisk’s OZEMPIC, RYBELSUS, WEGOVY).
Biosimilar litigation
Eculizumab: Alexion was successful in its patent infringement action against Amgen relating to BEKEMV, a biosimilar of Alexion’s SOLIRIS, with the Federal Court granting an injunction. The trial of Alexion’s patent infringement asserting the same patent against Samsung Bioepis relating to its biosimilar EPYSQLI is scheduled for July 2025. Another patent trial relating to a different patent between Alexion and both Amgen and Samsung Bioepis is scheduled to begin in November 2025.
Aflibercept: The trial of a patent infringement action pursuant to the PMNOC Regulations brought by Bayer and Regeneron against Amgen relating to Amgen’s ABP938, a biosimilar of Bayer’s EYLEA, took place in May and June 2025. A further patent infringement trial between the same parties but relating to different patents is scheduled to commence in August 2025. There are ongoing patent infringement actions by Bayer and Regeneron, including pursuant to the PMNOC Regulations, relating to Sandoz’s AFQLIR; the first trial is scheduled to commence in October 2026.
Ustekinumab: JAMP sought leave to commence an application against Janssen under the abuse of dominance provisions of the Competition Act (the Act), relating to ustekinumab (Janssen’s STELARA and FINLIUS and JAMP’s JAMTEKI). This was the first application for leave to commence a proceeding under section 79 of the Act. On November 20, 2024, the Competition Tribunal dismissed JAMP’s application. Samsung Bioepis’s action to invalidate Janssen’s patent relating to ustekinumab and its biosimilar PYZCHIVA remains pending. Janssen’s motion for leave to counterclaim for infringement after PYZCHIVA was granted a notice of compliance was dismissed (Samsung Bioepis v Janssen, 2024 FC 1715).
Pertuzumab: In May 2025, Hoffmann-La Roche and Genentech commenced a patent infringement action pursuant to the PMNOC Regulations against Organon and Shanghai Henlius Biotech relating to POHERDY, a biosimilar of PERJETA. A trial date has not yet been set.
Market access
On August 1, 2024, Manitoba’s Biosimilar Initiative went into effect. Manitoba was the last province in Canada to implement a biosimilar policy that requires patients receiving funding under the Manitoba Pharmacare program for certain reference biologic drugs to transition to a biosimilar version, subject to case-by-case exceptions.
This biosimilar initiative is in addition to biosimilar programs in British Columbia, Alberta, Northwest Territories, Quebec, New Brunswick, Nova Scotia, Saskatchewan, Ontario, Newfoundland and Labrador, Yukon, and Prince Edward Island (listed in chronological order of introduction).
In general, once a biosimilar is approved and listed—either on a formulary (e.g., Quebec) or in a biosimilar initiative (e.g., British Columbia)—the provincial/territorial drug plans discontinue funding for the originator biologic. There is typically a six-month transition period, with medical exceptions for certain populations such as pregnant women or minors.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.