Canada’s biosimilar substitution policy: effects on competition and patient safety

Biosimilars/Research | Posted 01/10/2021 post-comment0 Post your comment

A critical review of Canada’s biosimilar substitution policy [1] finds that the scheme has focused on economic factors over other elements such as therapeutic efficacy and market competition. The authors suggest that Canada could learn from the European market, where switching policies retain choice for physicians and patients and promote competition. 

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As of 30 April 2021, Canada has approved 36 biosimilars. Canada has also implemented mandated switching policies in four of its provinces, which require patients to switch from an originator biological to a biosimilar for certain conditions [2].

Although non-medical switching has been economically successful in Canada, a critical review of the policy [1] suggests it has given less weight to other factors such as therapeutic efficacy, supply chain factors, and market competition.

The review article explains that decisions about biosimilar substitution are made at the provincial level in Canada. Alberta, British Columbia, New Brunswick and Quebec (representing around half of the Canadian population) have begun to implement non-medical switching policies for biosimilars. These policies require switching from an originator biological to a biosimilar primarily for economic reasons.

The Canadian practice differs from biosimilar substitution policies in the US and Europe, as it focuses on economics over clinical or marketplace factors. In Europe, non-medical switching is banned in most countries and in the US automatic substitution is only permitted for ‘interchangeable biosimilars’.

Several groups in Canada have criticized the biosimilars policy, the review explains. Physicians, medical societies, and some patient groups have argued that non-medical switching could adversely affect patient care. The review cites a report into the risks associated with non-medical switching authored by the Institut National d’Excellence en Santé et Services Sociaux (INESSS), which found that the scientific data are insufficient to support the safety of switching between originator biological and biosimilar, particularly for inflammatory bowel disease (IBD) and oncology. Non-medical switching has not been supported by some clinicians due to the potential destabilization of complex patients.

In line with this, the Canadian Association of Gastroenterology and Crohn’s and Colitis Canada do not recommend non-medical switching for patients who are stable on a biological treatment. Similarly, the Gastrointestinal Society of Canada has stated that reimbursement policies should respect a physician’s right to prescribe based on clinical evidence and a patient’s right to choose a therapy.

The review suggests that mandatory, non-medical switching does not consider that not all patients respond to medications in the same way and that this may ultimately increase the financial burden on healthcare systems. For example, one article identified higher rates of surgery, increased steroid use and biosimilar dose escalations associated with non-medical switching.

The review also suggests that non-medical switching could adversely impact market competition. The authors say that, while short-term savings may be made under non-medical switching policies, in the long term there may be fewer product launches as a result. Other potential negative effects of a non-medical switching policy include potential drug shortages where there are not enough suppliers of a particular biosimilar and reduced choice for physicians and patients.

The article concludes that in order to create a sustainable biosimilars market, Canada could learn from more mature markets such as those in Europe, where switching policies put patient needs first, give physicians and patients more choice, and promote market competition.

Conflict of interest
This paper [1] is funded by the Alliance for Safe Biologic Medicines (ASBM). PJ Schneider is a member of the International Advisory Board of ASBM and Chair of the International Advisory Board of ASBM. MS Reilly is the Executive Director of ASBM.

Full details of the competing interests are available in the paper [1].

Editor’s comment
Readers interested to learn more about biosimilar substitution are invited to visit to view the following manuscripts published in GaBI Journal:

European prescribers’ attitudes and beliefs on biologicals prescribing and automatic substitution

Global policies on pharmacy-mediated substitution of biosimilars: a summary

Pharmacy-mediated substitution of biosimilars – a global survey benchmarking country substitution policies

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

GaBI Journal Citation Impact
1.9 – CiteScore 2020 (calculated on 5 May 2021)
2.0 – CiteScoreTracker 2021 (Last updated on 4 September 2021)

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1. Schneider PJ, Reilly MS. A critical review of substitution policy for biosimilars in Canada. Generics and Biosimilars Initiative Journal (GaBI Journal). 2021;10(3):123-9. doi:10.5639/gabij.2021.1003.016
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 1]. Available from:

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