Arthritis Consumer Experts (ACE) has been learning about biosimilars since 2009 and has become a national thought leader, conducting biosimilar workshops and sharing education with multi-stakeholder groups across Canada. The ACE biosimilars dialogue across Canada has included patients, health care professionals and policy decision makers in government and private health insurance.

Annual spending on biologics continues to rise dramatically for public and private drug plans in Canada.  At the same time, 55 Health Canada approved biosimilar biologics are now available, including biosimilar options for two of Canada’s biggest selling originator biologics – Remicade and Humira. With a roughly 40%-50% discount on the price of originators (depending on molecule), biosimilars offer significant savings to private and public drug plans. In 2022, biosimialrs accounted for 13.7% of all spending on biologics, compared with 8.9% in 2021.[1] However, Canada ranks well below the OECD median for biosimilars market penetration, meaning most of our private and public drug plans haven’t realized the savings that many other countries have, like Norway, the United Kingdom, Italy, Sweden, France, and Germany, to the benefit of patients and their healthcare systems.[2] Since biosimilar medicines have been available in 2006, healthcare systems were able to reinvest $25 billion total savings across Europe.[3]

The leading regulators in the world – including the European Medicines Agency, Food & Drug Administration in the U.S and Health Canada – support well-controlled transitions to biosimilars. Patients need to know transition policy has been safely and effectively implemented over the past 19 years with hundreds of thousands of patients with autoimmune diseases such as inflammatory arthritis in many countries in Europe with no compromise to patient safety, effectiveness or quality of care.

For the past eight years, federal, provincial, territorial and private insurance drug plans in Canada have mandated the use first of biosimilar versions ahead of their originators for treatment-naïve patients (patients who have not previously received the biologic in question). Since 2019, public drug plans have also begun implementing biosimilar transition policies that change coverage for specific biologic medicines. 

Biosimilars Transition Policy in Canada

In the context of biosimilar use, Health Canada considers transitioning or "switching between authorized products to refer to a change from routine use of one specific product to routine use of another specific product. Patients and health care providers can have confidence that biosimilars are effective and safe for each of their authorized indications. No differences are expected in efficacy and safety following a change in routine use between a biosimilar and its reference biologic drug in an authorized indication.”[4]

During the period of transition policy implementation, the drug plans cover both originator and biosimilar medicines for the affected diseases, providing time for patients to understand the biosimilar transition and their treatment options with their specialists. Following the end of a transition period, the drug plans only cover the biosimilar versions for the treatment of diseases affected by the transition policy. Patients unable to transition or who have an adverse response to the biosimilar can seek exceptional “special authority” coverage for the originator.

Prince Edward Island became the latest province or territory to expand the use of biosimilars when it launched on October 12, 2023, its Biosimilar Initiative where those covered under the PEI Pharmacare program will have until June 30, 2024, to work with their health care providers to a biosimilar version of their originator biologic.[5]

On March 29, 2023, the Government of Yukon announced it was enhancing the public drug plan with the implementation of a new policy where affected Yukoners enrolled in Pharmacare or the Chronic Disease and Disability Benefits program transitioned from their current biologic drug to a biosimilar.[6]

Newfoundland and Labrador became the ninth Canadian province and territory on March 24, 2023, to implement biosimilars transition policy, which moved patients from certain originator biologics to the biosimilar versions.[7]

Commenting on the implementation of biosimilar transition policy, Sylvia Jones, Ontario Deputy Premier and Minister of Health said: "Ontario is joining other provinces and territories in the country by expanding the use of safe and effective biosimilar drugs. Patients will continue receiving the same high-quality treatment, while allowing the government to fund more new drug therapies, bring innovation to the health care system and continue its work to deliver better, connected patient care."[8]

Starting on March 31, 2023, Ontario Drug Benefit (ODB) recipients who are on an originator biologic began transitioning to a Health Canada approved biosimilar version of the drug at no cost.[9]

In November 2022, Saskatchewan launched its Biosimilar Initiative, where approximately 24,000 existing patients already receiving an originator biologic,  transitioned to a  biosimilar version.[10]

Nova Scotia announced its new transition policy in February 2022, which involved medications used for inflammatory arthritis, inflammatory bowel disease and psoriasis, as well as certain insulins used to treat diabetes.[11]

In December 2021, Northwest Territories launched a Biosimilars Initiative with expected savings from the implementation of transition policy is to be reinvested to help fund coverage by increasing the medications that the supplementary health benefits programs cover in the future.[12]

Quebec changed its coverage in May 2021 for certain originator medications through the Public Prescription Drug Insurance Plan and required patients to transition from the originator medicine that they were on to a biosimilar version of that medicine.[13]

In April 2021, New Brunswick launched its Biosimilars Initiative, which involved transitioning patients from originator biologic medicines to their biosimilar versions.[14]  

Alberta announced in December 2019 its Biosimilar Initiative to expand the use of biosimilar medications through transition policy, explaining “patients will continue receiving the same safe and effective treatment, but at a lower cost.”[15]

In May 2019, British Columbia was the first province to implement biosimilars transition policy. Since implementation, B.C. has reported that thousands of patients living with inflammatory arthritis, diabetes and inflammatory bowel disease have been safely transitioned.[16] Through the launch of its biosimilars switching policy, British Columbia stated it is improving the sustainability of its PharmaCare program by adding new medicine listings and boosting existing medication coverage for patients.[17]

For up-to-date information about biosimilars policies for each provincial and territorial public drug plan, please click here.

Why are public drug plans transitioning patients from an originator biologic to a biosimilar biologic? 

A key benefit of transitioning patients is hundreds of millions of dollars in cost savings to the healthcare system. Biosimilars have the potential to improve access to biologics (both originators and biosimilars) and save public and private healthcare systems billions of dollars now, and over the coming years. 

A study commissioned by the Canadian Government’s Patented Medicine Prices Review Board (PMPRB) has estimated that private and public drug plans across Canada could save from $332 million CDN to $1.81 billion CDN in the third year following biosimilar entry across a portfolio of products.[18]

According to the Ontario Drug Policy Research Network: “Utilization and public spending on biologic drugs continue to grow in Ontario, with a projected annual spending of nearly $1.4 billion in 2021. In contrast, uptake of biosimilars has been low, with less than 1 in 5 biologic users accessing these less costly medications when they are available. Initiatives should be explored that could increase the utilization of biosimilars, given the large potential for cost savings for the government.”[19]

The Patent Medicines Prices Review Board estimates that Ontario could save more than $200 million annually with the implementation of its biosimilar policy.[20] At the launch announcement, the Ontario government stated the biosimilar transition policy will allow Ontario to invest more in new and innovative drug therapies and continue to grow the roster of publicly funded life-saving drugs.

At the announcement of the third phase expansion of its Biosimilars Initiative program in August 2020, the B.C. government stated this next phase would allow it to put another $30.7 million over the next three years, in addition to the $96.6 million from earlier phases of the Biosimilars Initiative, back into BC’s healthcare system.[21] In April 2021, the B.C. government added another biosimilar (adalimumab) for provincial coverage, citing additional savings of over $100 million over three years.[22]

When it announced its biosimilar transition policy in December 2019, the Alberta government claimed switching to biosimilars would save between $227 million and $380 million over the next four years once fully implemented.[23] Quebec's biosimilar policy is expected to generate annual savings of $100 million by 2022, which will be reinvested in Quebec's healthcare system and will help improve access to innovative drug therapies.[24] In Saskatchewan, the Ministry of Health estimates that the province will see annual savings of approximately $20 million once patients complete the transition to biosimilars by May 1, 2023.[25]