In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, market access and competition) since our last update in June 2022.
Biosimilars approved in Canada
Health Canada has approved four biosimilars since our last update:
- Baxter’s MYXREDLIN, biosimilar of Novo Nordisk’s NOVOLIN (human insulin, recombinant)
- Lupin Pharma’s RYMTI, biosimilar of Immunex’s ENBREL (etanercept)
- Fresenius Kabi’s ELONOX and ELONOX HP, biosimilars of Sanofi’s LOVENOX and LOVENOX HP (enoxaparin sodium)
- Celltrion’s VEGZELMA, biosimilar of Hoffmann La Roche’s AVASTIN (bevacizumab)
This brings the total biosimilars approved to 51 biosimilars of 16 innovator reference products, an increase of one innovator reference product since our last update with the first approval of a human insulin (recombinant) biosimilar, MYXREDLIN.
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 March 24, 2023) identifies the following biosimilar submissions under review, which includes submissions on IP hold:
- Eculizumab – the first biosimilar submission for this reference product
- Enoxaparin sodium
- Pegfilgrastim (two separate submissions)
- Ustekinumab – the first biosimilar submission for this reference product
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.
In August 2022, the Federal Court dismissed AbbVie’s applications for judicial review of the Minister of Health’s decisions that (1) JAMP was not a “second person” and therefore it was not required to address the patents listed on the Patent Register and (2) notices of compliance (NOCs) could issue for two high concentration presentations of JAMP’s SIMLANDI, a biosimilar of AbbVie’s HUMIRA (adalimumab). The Federal Court found that the Minister of Health's interpretation of s. 5(1) of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) as applying only to the drug identification number-specific version of the innovator’s drug that is marketed in Canada was reasonable. AbbVie has appealed.
The trial of infringement and invalidity actions relating to adalimumab between AbbVie and JAMP were heard in November and December 2022. The Court reserved its decision.
Patent infringement actions by Bayer, including one pursuant to the PMNOC Regulations, regarding BGP Pharma/Viatris’s YESAFILI, a biosimilar of Bayer’s EYLEA, are ongoing. The earliest trial is scheduled for March 2024.
Health Canada revised its Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs in August 2022. For submissions filed after receipt of an initial NOC to extend indication(s) to align with those of the reference product, where there is no or minimal data required, Health Canada will generally apply labelling-only fees and timelines (see Health Canada’s Notice).
In the United States, four biosimilars are designated as interchangeable by the FDA, meaning (subject to any state law) they may be substituted at the pharmacy for the reference product without the intervention of the prescribing health care provider:
- CIMERLI, a ranibizumab biosimilar of LUCENTIS;
- CYLTEZO, an adalimumab biosimilar of HUMIRA;
- REZVOGLAR and SEMGLEE, insulin glargine biosimilars of LANTUS
In September 2022, the European Medicines Agency and Heads of Medicines’ Agencies issued a joint statement confirming that biosimilars approved in the European Union are interchangeable, explaining that “[i]nterchangeability in the context of this statement means using one medicine instead of another with the same therapeutic intent. This definition does not include automatic substitution at the pharmacy level, the decision on which is the responsibility of the individual member states.”
In Canada, as explained in Health Canada’s Biosimilar biologic drugs in Canada: Fact Sheet, the authorization of a biosimilar by Health Canada is not a declaration of equivalence to the reference biologic drug. Further, Health Canada does not have the authority to declare two products interchangeable, as this authority rests with each province and territory according to its own rules and regulations. While no province or territory has declared any biosimilars as interchangeable with the reference biologic, many have reimbursement policies that provide for biosimilar switching.
- October 20, 2022 – the Saskatchewan Biosimilars Initiative was announced, and patients are expected to transition to listed biosimilars by April 30, 2023.
- December 20, 2022 – Ontario announced that patients receiving coverage from the Ontario Drug Benefit will transition to biosimilars, subject to exemptions, between March 31, 2023 and December 29, 2023.
- March 24, 2023 – Newfoundland and Labrador announced that patients using certain originator biologics will transition to biosimilar versions on or before March 31, 2024.
These three biosimilar initiatives are in addition to biosimilar programs in British Columbia, Alberta, Northwest Territories, Quebec, New Brunswick, and Nova Scotia. In each of these jurisdictions, in general, switching is mandated as new biosimilars are approved and covered by their respective drug programs.
The Patented Medicine Prices Review Board’s CompassRx, 8th edition: Annual Public Drug Plan Expenditure Report, 2020/21 includes data on the impact of biosimilars on prescription drug spending by public drug plans participating in the National Prescription Drug Utilization Information System (which excludes Quebec). Price discounts for biosimilars ranged from 25% to 50%. Biosimilars of filgrastim and pegfilgrastim had 94% and 100% share of prescriptions for these molecules, while the share of the market for other biosimilars ranged from 0.1% (insulin lispro) to 51.4% (etanercept).
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 technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.