Biosimilars approved in Canada
Biosimilar submissions under review
Biosimilar litigation
Regulatory
Market access
Since April 2021,(1) there have been many developments regarding biosimilars in Canada, including approvals, pending submissions, litigation, regulatory and market access.
Biosimilars approved in Canada
Health Canada has approved three biosimilars since April 2021:
- 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); and
- Tanvex Biopharma's NYPOXI, a biosimilar of Amgen's NEUPOGEN (filgrastim).
This brings the total biosimilars approved to 39 biosimilars of 14 innovator products.(2)
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 25 October 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; and
- Trastuzumab (2).
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 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.
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 section 8 action against Amgen, and Amgen discontinued its actions against other biosimilar manufacturers.(3)
Infliximab
The litigation between Janssen and Hospira relating to the biosimilar INFLECTRA has been discontinued.(4)
Adalimumab
The litigation between adalimumab biosimilar manufacturers Fresenius Kabi (IDACIO) and Samsung Bioepis (HADLIMA), believed to be the first biosimilar versus 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.
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 predetermined milestones and targeted review timeframes.
Quebec is the latest province to require that, with some exceptions, prescribers switch patients to a biosimilar by 12 April 2022.(5) 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, paediatric 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. Quebec'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 28 February 2022.
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-naive 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.
For further information on this topic please contact Urszula Wojtyra at Smart & Biggar by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar website can be accessed at www.smartbiggar.ca.
Endnotes
(1) For further information, please see "Update on biosimilars in Canada - April 2021".
(2) A complete list of approved biosimilars is regularly updated and available to view here.
(3) For further information, please see "Supreme Court of Canada denies Amgen leave to appeal decision invalidating its filgrastim patent".
(4) For further information, please see "Federal Court of Appeal remands REMICADE new use patent decision on anticipation and obviousness".
(5) For further information, please see "Quebec initiating a shift to use of biosimilar drugs".