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 October 2021.
Biosimilars approved in Canada
Health Canada has approved eight biosimilars since our last update:
- Celltrion's YUFLYMA and JAMP's SIMLANDI, both marketed, biosimilars of AbbVie's HUMIRA (adalimumab)
- BGP Pharma's ABEVMY, now marketed, and Samsung Bioepis's AYBINTIO, biosimilars of Hoffmann La Roche's AVASTIN (bevacizumab)
- Pfizer's IXIFI, biosimilar of Janssen's REMICADE (infliximab)
- BGP Pharma's SEMGLEE, biosimilar of Sanofi-Aventis's LANTUS (insulin glargine)
- Samsung Bioepis's BYOOVIZ, the first biosimilar of Novartis's LUCENTIS (ranibizumab)
- Samsung Bioepis's ONTRUZANT, biosimilar of Hoffmann La Roche's HERCEPTIN (trastuzumab)
This brings the total biosimilars approved to 47 biosimilars of 15 innovator reference products, up from the previous 14 with the first approval of a ranibizumab biosimilar. For comparison, the European Medicines Agency has 69 biosimilars approved of 18 innovator products. Of those 18, Canada does not have biosimilars of epoetin alfa or follitropin alfa, and does not have an approved epoetin zeta innovator reference product. 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 22, 2022) identifies the following biosimilar submissions under review, which includes submissions on IP hold:
- Aflibercept – the first biosimilar submission for this reference product
- Enoxaparin sodium
- Human insulin (recombinant)
- Pegfilgrastim (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.
Patent infringement and invalidity actions between AbbVie (sponsor of the adalimumab reference biologic HUMIRA) and JAMP regarding its biosimilar SIMLANDI remains pending. The trial of the actions is scheduled to start in November 2022.
Separate from the patent litigation, AbbVie has applied for judicial review of the Minister of Health's decision that JAMP is not a second person under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for its biosimilar SIMLANDI, and to quash JAMP's notice of compliance for SIMLANDI. The judicial review applications were heard by the Federal Court in May 2002, and a decision is under reserve.
The previously reported litigation between adalimumab biosimilar manufacturers Fresenius Kabi (IDACIO) and Samsung Bioepis (HADLIMA), believed to be the first biosimilar vs. biosimilar patent litigation in Canada, was discontinued in March 2022.
In June 2022, Bayer commenced a patent infringement action against BGP Pharma and Viatris under the PMNOC Regulations regarding BGP Pharma's proposed aflibercept biosimilar YESAFILI (Bayer's EYLEA). Two additional defendants were also named, but the names are sealed pursuant to a Court Order.
Health Canada launched a consultation on its proposed Handbook for healthcare professionals on biosimilar biologic drugs. The Handbook was developed with the goal of informing and educating healthcare professionals in Canada regarding biosimilars, and provides information on biosimilar development, authorization and potential use.
In December 2021, the Government of Northwest Territories (GNWT) launched a Biosimilars Initiative to switch patients to biosimilars over a six-month transition period. In February 2022, Nova Scotia announced that, subject to approved exemptions, patients enrolled in that province's pharmacare programs would have one year to switch to biosimilars of certain drugs. The policy will apply to other medications on the Nova Scotia Formulary as new biosimilar medications are approved.
These two biosimilar initiatives are in addition to the ongoing biosimilar programs in British Columbia, Alberta, New Brunswick, and Quebec. In each of these provinces, in general, switching is mandated as new biosimilars are approved and covered by their respective drug programs.
The Telus Health 2022 Drug Data Trends and National Benchmarks report concluded that the BC switching policy "has had a profound impact on private plans in that province." The BC biosimilar initiative prompted private plans to copy the government's switching policy. The effect in BC on private drug plans is evident when compared to the rest of Canada: in December 2021, private drug plan biosimilars' share of the total eligible amount for biologics with biosimilar options was 65% in BC, compared to 12% in the rest of Canada.
As per our previous updates, in Ontario, the reimbursement criteria for biosimilars are less restrictive for most indications as compared to the reference biologic. This policy was similarly implemented for insulin aspart and insulin glargine biosimilars (Ontario Ministry of Health Notice, Insulin glargine FAQ and Insulin aspart FAQ). Ontario continues not to require treatment-experienced patients to switch to a biosimilar; however, treatment-naïve patients will only be funded for an approved and listed biosimilar.
The Patented Medicine Prices Review Board prepared a poster, "Canada's Evolving Market for Biosimilars and What It Means for Payers," providing an overview of the market for biosimilars in Canada compared to international counterparts in 2020. For six of the 11 molecules for which biosimilars were marketed in Canada in 2020, biosimilars in Canada had a share of the market that was higher or similar to the OECD median. A comparison of the uptake of infliximab biosimilars in Canada versus BC from 2017-2021 shows that by the end of 2021, infliximab biosimilars constituted 94% of the BC market, compared to 30% in the rest of Canada. According to a table outlining current provincial initiatives to encourage switching to biosimilars, all provinces except Saskatchewan are "planning to implement biosimilar switching strategies."
On June 27, 2022, the Competition Bureau announced it completed a preliminary investigation into potential anti-competitive harm from "relabelled" biologic drugs: biologics that are identical to originator biologic drugs but marketed under a different brand name (sometimes known as "biosame" or "authorized biologics"). The investigation was closed because the relabelled drugs, which are not identified in the announcement or accompanying position statement, were not marketed in Canada. However, the Bureau stated that based on preliminary information, "in some cases, relabelling drugs could harm competition by making it less likely that patients will switch away from the original drug [and] may reduce incentives for pharmaceutical companies to develop and market biosimilars."
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.