Ontario Expanding Safe Use of Biosimilars
TORONTO — Ontario is joining several other provinces and territories by expanding the use of biosimilar drug treatments for Ontarians. Starting March 31, 2023, Ontario Drug Benefit (ODB) recipients who are on an originator biologic will begin to transition to a Health Canada approved biosimilar version of the drug at no cost.
“Ontario is joining other provinces and territories in the country by expanding the use of safe and effective biosimilar drugs,” said Sylvia Jones, Deputy Premier and Minister of Health. “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.”
Patients and health care providers can be confident that the quality, safety and patient benefits of the biosimilar are highly similar to the biologic drug. Biosimilars undergo the same robust and rigorous approval process by Health Canada and to be approved in Canada, a biosimilar must be proven to be highly similar, with no clinically meaningful differences in terms of safety and efficacy.
Ontarians receiving coverage under the ODB program for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan®, will be required to transition to the biosimilar version by December 29, 2023. During the transition period between March 31 and December 29, 2023, patients are encouraged to discuss a transition plan with their health care provider through in-person, telephone or virtual visits. Exemptions will be considered for patients in certain clinical circumstances on a case-by-case basis in consultation with their health care provider.
Ahead of the transition period starting on March 31, 2023, the ministry will continue to work with partners, including physicians, pharmacists and manufacturers, to ensure a smooth and successful transition. This switch will allow Ontario to invest more in new and innovative drug treatments and continue to grow the roster of publicly funded life saving drugs.
Biosimilars have been used in the European Union for more than 15 years and Ontario is the eighth Canadian jurisdiction to expand the use of biosimilar medications, following British Columbia, Alberta, New Brunswick, Quebec, Northwest Territories, Nova Scotia and Saskatchewan.
Biologics are drugs made with living organisms (e.g., yeast or animal cells), rather than being synthetically manufactured, and are often used to treat patients with chronic health conditions such as rheumatoid arthritis, inflammatory bowel disease, and diabetes. An originator biologic is the first version of a biologic drug.
Biosimilars are biologic drugs that enter the market after the patents or data protection rights for the originator biologic expire, have similar effectiveness, safety, and quality as the originator biologic and have been approved for use in Canada by Health Canada.
"Expanding the use of biosimilars will support the sustainability of Ontario’s drug program by encouraging companies to bring more products to market which will provide patients with the high quality treatments and support services they need and deserve. Biosimilars Canada and its member companies congratulate the Government of Ontario for moving ahead with a biosimilars switching policy and remain committed to working with the government, specialists and stakeholders to ensure the smooth transition to biosimilars for Ontarians."
- Jim Keon President, Biosimilars Canada
"We applaud the Ontario government’s decision to adopt a biosimilar switch policy. Not only will this deliver meaningful savings which can be reinvested elsewhere in the healthcare system, but importantly, it provides increased access and options for patients instead of relying on more expensive brand-name biologic products."
- Jeff Watson President and CEO, Apotex
"Arthritis Society Canada believes a switch to a biosimilar can take place safely under the right conditions, can improve access to treatment and provide savings to the healthcare system. We look forward to working with the Ontario government to ensure the transition is seamless for patients and their families. Arthritis Society Canada has educational and support materials available to help patients and families learn more about biosimilars."
- Dr. Siân Bevan Chief Science Officer, Arthritis Society Canada
"Today’s drug policy announcement will help ensure continued reimbursement coverage for patients with inflammatory arthritis who transition to a biosimilar biologic. Biosimilars are as effective and safe as originator biologics but are available at a much lower cost. Based on the successful patient experience in B.C, Alberta, Quebec and other provinces and territories, patients should feel confident about the transitioning and that the Ontario government will reinvest savings into their healthcare system, especially at this time when resources to maintain and improve patient care are urgently needed."
- Cheryl Koehn Founder and President, Arthritis Consumer Experts
"Both biologics and biosimilars have gone through rigorous standards for authorization by Health Canada, to which both have been found safe and effective for use in Inflammatory Bowel Disease (IBD). CDHF knows having to change any kind of medication can be very stressful. While we believe in patient-physician choice, we acknowledge political policy decisions and our organization is committed to providing clear and unbiased information on biosimilars."
- Kelsey Cheyne Executive Director, Canadian Digestive Health Foundation
"Pfizer supports the Ministry of Health’s efforts to expand access to cost-effective biosimilar treatments for Ontario residents."
- Frederic Lavoie Pfizer Canada
"I have been following the development of the Biosimilars for over 10 years, and experience in other countries and more recently in sister provinces has convinced and reassured me that physician-supervised switching is a safe and effective in clinical practice, and supported by numerous studies. Biosimilars are not new and are approved by Health Canada as safe and effective, with over 50 biosimilars currently approved for use in Canada."
- Dr. Carter Thorne Chair, Centre of Arthritis Excellence
"The Ontario Rheumatology Association has been a longstanding supporter of a biosimilar switch policy as we know that biosimilars are safe and effective for our patients and will result in significant cost savings to the health care system."
- Dr. Felix Leung President, Ontario Rheumatology Association