Ontario Biosimilars Policy
What is Changing in the Ontario Coverage for Biologics?
Ontario is joining several other provinces and territories by expanding the use of biosimilar drug treatments for Ontarians.
The Ontario Drug Benefit (ODB) is implementing some changes to their biologics coverage. Under the new policy, there will be a nine-month transition period that is set to start March 31st, 2023 where recipients who are on an originator biologic will begin to transition to a Health Canada approved biosimilar version of the drug at no cost. That will allow patients time to have discussions with their care providers about what the changes mean, as well as their options. For those with Inflammatory Bowel Disease (IBD) who are being administered Humira (adalimumab), or Remicade (infliximab) you will be required to transition to a biosimilar.
This initiative follows similar efforts elsewhere in Canada namely British Columbia, Alberta, Quebec, New Brunswick, and Northwest Territories. Tens of thousands of Canadians have safely switched to a biosimilar in those initiatives. They are also used extensively in Europe, where countries have had over 15 years of experience with biosimilars.
- Patients will have until end of December 29, 2023 to talk to their healthcare provider to receive a new prescription for the biosimilar
To switch to a biosimilar, you should:
- Contact your health care provider
- Check the list of drugs affected to determine if you need to make the switch
- Receive a new prescription of the biosimilar version of your medication
Are there exemptions to the switch?
Yes, In some cases, patients may need to continue using the reference biologic for medical reasons. Exemptions to the initiative will be considered on a case-by-case basis, in consultation with their health care provider.
CDHF Biosimilar Library
Frequently Asked Questions
1. What is a biologic?
Biologic (reference) drugs are medications made by using living organisms (such as yeast or animal cells) to produce complex proteins that are purified then administered to affect certain processes in the human body.
2. What is a biosimilar?
A biosimilar is a drug demonstrated to be highly similar to a biologic (reference) drug, that has been authorized for sale in Canada.
3. What do experts say about the safety and efficacy of biosimilars?
Health Canada is responsible for ensuring the safety, efficacy, and quality of all new drugs including biologics and biosimilars. For a biosimilar drug to be approved in Canada, Health Canada must find no meaningful differences in safety and effectiveness compared to the biologic.
“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.”
4. Do I have to switch to a biosimilar?
As part of the biosimilars initiative, if you receive coverage through an Ontario Drug Benefit (ODB) plan and you currently take Remicade® or Humira® for the treatment of Crohn’s disease or ulcerative colitis, you must switch to the biosimilar version before the end of the transition period (December 29, 2023 ) to avoid any disruption to your coverage. There may be medical reasons why you cannot switch to a biosimilar. Your healthcare provider can help you determine if it is medically necessary to remain on a biologic (reference) drug and will confirm if you qualify for an exemption.
5. Why is the change happening?
Transitioning to biosimilars will allow province to invest in and improve access to medicines.
The Ontario Drug Benefit (ODB) is the largest drug plan in Canada, accounting for about 40% of public drug spending in the country. Ontario is the province that is home to the nation’s capital (Ottawa) and its most populated city (Toronto). The measure also comes after Biosimilars Canada, a national association representing the biosimilar industry in Canada, held a press conference to pressure Premier Doug Ford’s administration to implement a biosimilar switching policy in October 2022.
Sylvia Jones, Ontario’s Health Minister, confirmed that the transition to biosimilars will enable Ontario to invest more money in new drug treatments and continue to grow its roster of publicly funded medications.
6. How do I maintain my coverage?
To maintain your coverage:
- Make an appointment to speak with your healthcare provider to discuss switching
- Your healthcare provider can explain the switch process, answer any questions you may have, register you with the new patient support program, have your new prescription into place.
- Make sure you have spoken with your healthcare provider and initiated your biosimilar switch by end of December 29, 2023.
CDHF Resource Links
- Explore CDHF’s Biosimilar Library
- CDHFTalks: Your New Infusion Clinic.. Not the Same, but Similar.
- CDHF | Transition Pathway Brochure for IBD Patients
- CDHF | Biosimilars for IBD: Making the Transition Webinar
- CDHF | What’s Health Canada saying about Biosimilars Animation
- CDHF | What’s Health Canada saying about Biosimilars Infographic
- CDHF | IBD: Switching from a Biologic to a Biosimilar Animation
- Ontario News
- Health Canada Factsheet on Biosimilars
- Government of Canada | Guidance Documents: Information and Submission Requirements for Biosimilar Biologic Drug