In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, and market access) since our March 2023 update.
Biosimilars approved in Canada
Health Canada has approved four biosimilars since our last update:
- Baxter’s AXBERI and AXBERI HP, biosimilars of Sanofi’s LOVENOX and LOVENOX HP (enoxaparin sodium)
- Teva’s RANOPTO, biosimilar of Novartis’s LUCENTIS (ranibizumab)
- JAMP Pharma’s JAMTEKI and Amgen’s WEZLANA, biosimilars of Janssen’s STELARA (ustekinumab)
- Sandoz’s JUBBONTI and WYOST, biosimilars of Amgen’s PROLIA and XGEVA (denosumab)
There are now 56 biosimilars approved in Canada of 18 innovator reference products, an increase of two innovator reference products since our last update with the first approvals of ustekinumab and denosumab 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 March 18, 2024) identifies the following biosimilar submissions under review, which includes submissions on IP hold:
- Aflibercept (four separate submissions)
- Denosumab
- Eculizumab (three separate submissions)
- Filgrastim
- Omalizumab – the first biosimilar submission for this reference product (Novartis’ XOLAIR)
- Pegfilgrastim (four separate submissions)
- Rituximab
- Tocilizumab – the first biosimilar submission for this reference product (Roche’s ACTEMRA)
- Trastuzumab
- Ustekinumab (three 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 are under review by Health Canada for liraglutide (Novo Nordisk’s VICTOZA, SAXENDA, XULTOPHY) and semaglutide (Novo Nordisk’s OZEMPIC, RYBELSUS, WEGOVY).
Biosimilar litigation
Adalimumab: In December 2023, the Federal Court held that JAMP’s SIMLANDI, a biosimilar of AbbVie’s HUMIRA infringed one of AbbVie’s patents, but did not enjoin JAMP from continuing to sell SIMLANDI. An appeal is pending. On April 9, 2024, the Federal Court of Appeal will hear AbbVie’s appeal of the Federal Court decision holding that the Minister of Health was reasonable in finding that JAMP was not a “second person” and therefore it was not required to address the patents listed on the Patent Register in connection with its two high concentration presentations of SIMLANDI.
Aflibercept: Patent infringement actions by Bayer and Regeneron against Biosimilar Collaborations Ireland (Biocon Biologics) relating to its YESAFILI, a biosimilar of Bayer’s EYLEA, were discontinued prior to trial, which was scheduled for March 2024. There are ongoing patent infringement actions by Bayer and Regeneron, including pursuant to the PMNOC Regulations, relating to Amgen’s ABP938,Celltrion’s EYDENZELT, and Apotex’s AFLIVU.
Eculizumab: Patent infringement actions by Alexion against Amgen relating to its BEKEMV and against Samsung Bioepis relating to its EPYSQLI, both biosimilars of Alexion’s SOLIRIS, are ongoing.
Ustekinumab: Samsung Bioepis has commenced an action seeking to invalidate Janssen’s patent relating to ustekinumab. Samsung Bioepis has a submission pending for PYZCHIVA, a biosimilar of Janssen’s STELARA.
Trademark litigation
Novartis obtained a permanent injunction from the Federal Court preventing Biogen and Samsung Bioepis from using the trademark BYOOVIZ for its ranibizumab biosimilar of Novartis’s LUCENTIS, holding that it was confusingly similar to Novartis’ BEOVU trademark. The Federal Court of Appeal stayed the Federal Court’s injunction and expedited the appeal, which is pending.
Regulatory
Health Canada released a Handbook for health care professionals on biosimilar biologic drugs, to inform and educate health care professionals on biosimilars. Among other things, the Handbook provides overviews of Health Canada’s approach to biosimilar authorization and data requirements, and provides a case study of two biosimilars.
Health Canada also issued a Policy statement: Content of product monograph for biosimilar biologic drugs – clinical comparative study results, stating that product monographs for biosimilar products should not include comparative clinical study results. The Policy states that “the establishment of similarity is principally demonstrated by comparative structural and functional studies” and that the previous product monograph format placed unnecessary emphasis on clinical studies. Comparative clinical study results will continue to be included in Health Canada’s Summary Basis of Decision available online for the approved biosimilar.
Market Access
Since our last update on biosimilars, one further province and one territory launched biosimilar transition policies:
- On March 29, 2023, the Government of Yukon announced the Yukon Biosimilar Initiative. The first phase switched patients taking adalimumab and insulin glargine; the second phase includes six further biosimilars and the switching period ends May 8, 2024.
- On October 12, 2023, Prince Edward Island announced its PEI Biosimilar Initiative. Subject to exemptions, patients are expected to switch by June 30, 2024, for certain insulin biosimilars, and September 30, 2024, for other listed biosimilars.
These two biosimilar initiatives are in addition to biosimilar programs in British Columbia, Alberta, Northwest Territories, Quebec, New Brunswick, Nova Scotia, Saskatchewan, Ontario and Newfoundland and Labrador (listed in chronological order of introduction).
The Patented Medicine Prices Review Board’s CompassRx, 9th edition: Annual Public Drug Plan Expenditure Report, 2021/22 includes an overview of the biosimilar switching initiatives by Canadian public payers (Appendix C) as well as 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 relative to the reference products ranged from 15% to 50%. Biosimilars of filgrastim and pegfilgrastim had 94.5% and 99.9% share of prescriptions for these molecules, while the share of the market for other biosimilars ranged from 0.9% (insulin aspart) to 74.9% (rituximab).
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.