Biosimilars regulation in Canada: state of play

Biosimilars/Research | Posted 08/11/2019 post-comment0 Post your comment

A paper recently published in GaBI Journal provides an update on the regulation and reimbursement of biosimilars in Canada, including changes to the regulation on switching and processes for private plan reimbursement [1].

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Biological drugs are considered high-cost drugs; biologicals accounted for over 21.6% of prescription drug spending (CA$13.5 billion) in Canadian public drug programmes in 2017 and, in the private sector, seven of the top 10 selling high-cost drugs were biologicals.

To combat these costs, 15 biosimilars are expected to be launched in Canada by 2020, according to the Canadian Agency for Drugs and Technologies in Health (CADTH).

The review by Siu et al. [1] provides an update on the biosimilars market in Canada post-2016, since then four new biosimilars have launched in the country: Omnitrope (somatropin), Inflectra (infliximab), Grastofil (filgrastim) and Basaglar (insulin glargine).

There have also been significant changes to the regulatory and health technology assessment (HTA) domains in Canada, several of which are designed to promote biosimilars uptake.

The review article discusses new developments in these and several other areas, including:

Regulatory framework
Health Canada began a Regulatory Review of Drugs and Devices initiative in 2017 in order to improve access to drugs, make better use of evidence to support its regulatory decisions, modernise its operation and increase collaboration with both domestic and international partners.

There have also been changes to the naming convention for biosimilars in Canada. Health Canada and the Institute for Safe Medication Practices Canada initiated an online consultation on the naming of biological drugs in 2018. As a result, the government decided that biological drugs (including biosimilars) will be identified by their brand name and non-proprietary name, without the addition of a product-specific suffix [2]. It is hoped that the new naming system will support clear distinctions between biological drugs and enable better tracking of adverse events.

Health technology assessment (HTA) of biosimilars
HTA is an evidence-based process used in Canada to assess new healthcare innovations/medications. HTA recommendations, such as those provided by CADTH, are used as part of the decision-making process for public drug plans in Canada. A significant change in the role of CADTH in biosimilar reimbursement took place in 2019.

In May 2019, CADTH announced a change to how it would review biosimilar products, citing reasons including delay to new treatments. Although CADTH stated it would no longer review biosimilar submissions, it indicated that manufacturers should still submit their products to public jurisdictions and the pan-Canadian Pharmaceutical Alliance (pCPA).

There have been further changes to the pan-Canadian Oncology Drug Review (pCODR) and Institut national d’excellence en santé et en services sociaux (INESSS) review processes. These changes together aim to streamline the journey of biosimilar products and make the process of biosimilar approval more efficient.

pan-Canadian Pharmaceutical Alliance (pCPA)
The pCPA aims to combine purchasing power for public drug plans, in order to improve access to drugs and increase their cost-effectiveness. In 2016, the Alliance issued the Subsequent Entry Biologics First Principles in order to develop a more comprehensive policy framework for biosimilars.

Since then, the Alliance has completed several negotiations and in 2018 released a set of ‘Biologics Policy Directions’ including to: consider biological drugs on an individual basis, not consider offers for biological drugs that seek to restrict or exclude biosimilars, and implement switching from a reference to a biosimilar.

The ultimate aim of the policy directions is to develop a ‘clear and consistent pan-Canadian approach that encourages appropriate use of biologicals […] to enhance patient access to clinically relevant and cost-effective drug treatment options’.

Provincial/federal formularies
In a significant and unprecedented move, British Columbia has begun an initiative that promotes switching to biosimilars. Adopted in May 2019, British Columbia’s Biosimilars Initiative makes it the first Canadian province to stop coverage of originator biologicals and switch patients to biosimilars for certain indications [3]. The initiative aims to increase uptake of biosimilars and it is thought other provinces will follow suit.

The review article discusses these and several other changes in the Canadian biosimilars landscape in greater depth. The authors suggest that these developments will increase confidence in biosimilars among prescribers, patients and payers, subsequently increasing healthcare savings, which will be vital to sustain the Canadian national healthcare system.

Conflict of interest
Several of the authors are employees of Innomar Strategies, a consulting firm that has business dealings with both originator and biosimilar manufacturers. No consulting fees were accepted relating to the work of the manuscript. The authors have no other conflicts of interest to declare.

Editor’s comment
This article for GaBI Online is a summary of the full article published in GaBI Journal.

Readers interested to learn more about the Canadian biosimilars market are invited to visit to view the following manuscripts published in GaBI Journal:

Current state of subsequent entry biologics (biosimilars) in Canada: a view from regulatory, reimbursement, clinician, and patient perspectives

Health Canada’s perspective on the clinical development of biosimilars and related scientific and regulatory challenges

Subsequent entry biologics (biosimilars) in Canada: approaches to interchangeability and the extrapolation of indications and uses

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

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1. Siu ECK, Tomalin A, West K, et al. An ever-evolving landscape: an update on the rapidly changing regulation and reimbursement of biosimilars in Canada. GaBI Journal. 2019;8(3): Epub ahead of print
2. GaBI Online - Generics and Biosimilars Initiative. Health Canada announces naming convention for biologicals []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 4]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Canada’s British Columbia to switch patients to biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 4]. Available from:

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