Canada’s Intellectual Property Law Firm

Since our last update in April 2021, there have been many developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory and market access).

Biosimilars approved in Canada

Health Canada has approved three biosimilars since the last update, as listed below.

  • Apotex’s BAMBEVI, a biosimilar of Hoffmann La Roche’s AVASTIN (bevacizumab)
  • BGP Pharma’s KIRSTY, a biosimilar of Novo Nordisk’s NOVORAPID (insulin aspart)
  • Tanvex Biopharma’s NYPOXI, a biosimilar of Amgen’s NEUPOGEN (filgrastim)

This brings the total biosimilars approved to 39 biosimilars of 14 innovator products. The complete list of approved biosimilars is regularly updated and available to view now.

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 October 25, 2021) identifies the following biosimilar submissions under review, which includes submissions on IP hold, with the number of submissions listed in brackets:

  • Adalimumab (2)
  • Bevacizumab (3)
  • Etanercept (1)
  • Filgrastim (1) – company is Tanvex Biopharm, this is likely NYPOXI, now approved
  • Human insulin (recombinant) (1)
  • Infliximab (1)
  • Insulin aspart (1) – company is BGP Pharma, this is likely KIRSTY, now approved
  • Insulin glargine (1)
  • Ranibizumab (1) – biosimilar of Novartis’s LUCENTIS, no prior biosimilar approved
  • Trastuzumab (2)

There continue to be 3 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 the United States, the FDA has approved two interchangeable biosimilars: Mylan’s SEMGLEE, a biosimilar of Sanofi-Aventis’s LANTUS (insulin glargine), and Boehringer Ingelheim’s CYLTEZO, a biosimilar of AbbVie’s HUMIRA (adalimumab). Neither SEMGLEE nor CYLTEZO are approved in Canada. In Canada, the authority to designate drugs as interchangeable rests with the provinces and territories; thus far, no biosimilars have been designated as interchangeable.

Biosimilar Litigation

Filgrastim and pegfilgrastim:

  • The Supreme Court of Canada denied Amgen’s application for leave to appeal the November 2020 Federal Court of Appeal decision upholding the invalidity of Amgen’s patent relating to the filgrastim drug NEUPOGEN in an action relating to Pfizer’s biosimilar NIVESTYM. Pfizer discontinued its s. 8 action against Amgen, and Amgen discontinued its actions against other biosimilar manufacturers.

Infliximab:

Adalimumab:

  • 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, remains pending. The trial of the actions is scheduled for May 2022.
  • Similarly, the litigation between AbbVie (sponsor of reference biologic HUMIRA) and JAMP Pharma regarding its biosimilar SIMLANDI also remains pending. The trial of the actions is scheduled for November 2022.

Regulatory

Health Canada is part of the Access Consortium, which is a collaborative initiative of the governmental authorities that regulate human medicines from Australia, Canada, Singapore, Switzerland and the United Kingdom. In September 2021, Health Canada posted a document outlining information for industry in filing an international work sharing submission for biosimilars, titled “Facilitating Access Consortium Work Sharing for Biosimilars.” Biosimilar sponsors can participate, with advanced notice, by filing biosimilar applications in a coordinated fashion. The streamlined review process is then coordinated between the regulators to reduce duplication and increase predictability with pre-determined milestones and targeted review timeframes.

Market Access

As previously reported, Quebec is the latest province to require that, with some exceptions, prescribers switch patients to a biosimilar by April 12, 2022. This includes biosimilars of adalimumab, bevacizumab, etanercept, filgrastim, infliximab, insulin glargine, insulin lispro, pegfilgrastim, rituximab, and trastuzumab. According to the List of Medications, once a biosimilar is added to the List, a reference biologic drug is only covered by the basic prescription drug insurance plan in certain cases, including pregnant patients, pediatric patients, and patients who experienced a therapeutic failure with at least two other biologic drugs used to treat the same medical condition. Item 2.4 of the List also states that patients on a reference biologic drug for which a biosimilar is listed cannot obtain reimbursement for another originator biologic drug unless the prescriber confirms there was a therapeutic failure with the reference biologic drug. Québec’s website on biosimilar drugs includes a section on the current situation regarding reimbursement.

The biosimilar initiatives in British Columbia, Alberta and New Brunswick continue to require patients, with some exceptions, to be switched to biosimilars for certain indications. In Alberta, in addition to previously reported drugs, switching is currently mandated for enoxaparin, insulin lispro, insulin aspart and adalimumab by deadlines in 2022. In New Brunswick, in addition to previously reported drugs, patients must be switched to enoxaparin biosimilars by February 28, 2022.

As reported in our previous updates, in Ontario, the reimbursement criteria for infliximab, etanercept, filgrastim, pegfilgrastim, rituximab and adalimumab biosimilars are less restrictive for most indications as compared to the reference biologic. This policy was similarly implemented for recently funded enoxaparin biosimilar REDESCA (Ontario Ministry of Health Notice and Enoxaparin FAQ). Ontario continues to not require treatment-experienced patients to switch to a biosimilar; treatment-naïve patients will only be funded for an approved and listed biosimilar.

According to a recent blog post by Telus Health, on average, the list price of a biosimilar is more than half the list price of the reference product. The average biosimilar list prices range from 54% (infliximab) to 79% (insulin glargine) of the innovator list price.

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.