Biosimilars
Learn more about Health Canada approved biosimilar drug treatments.
Overview
On March 31, 2023, Ontario Drug Benefit (ODB) recipients who were on select originator biologics began to transition to a Health Canada approved biosimilar version of the drug within defined transition periods.
Going forward, as additional biologic drugs are added to the ministry’s biosimilar transition policy framework, a transition period will be provided. This will allow the patient to transition to the biosimilar version of the drug and expect the same treatment outcome.
Affected drugs
If you are taking one of the originator biologics listed in the table below, you will need to switch to a biosimilar version within the listed transition period to receive coverage for the biologic through the ODB program, unless an exception applies to you.
| Transition Period | Originator (Drug) |
|---|---|
| March 31, 2023, to December 28, 2023 |
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| July 31, 2024, to January 31, 2025 |
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| November 29, 2024, to August 29, 2025 |
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| November 29, 2024 to the earlier of August 29, 2025 or the date your approval under the Exceptional Access Program for Xgeva® expires |
|
| November 28, 2025 to May 28, 2026 |
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| November 28, 2025 to the earlier of May 28, 2026 or the date your approval under the Exceptional Access Program for Actemra® or Xolair® expires. |
|
Drugs not listed
If you are taking another ODB program covered biologic not listed above, it will still be covered. As new biosimilars are approved by Health Canada and enter the Canadian market, additional biologic drugs may be subject to this transition requirement. This webpage will be updated to reflect the applicable biologic drug and transition period.
Your specialist, doctor or nurse practitioner will need to provide you with a new prescription for the biosimilar version of the drug that you will be using. Ask your specialist, doctor, nurse practitioner or pharmacist for more information about how the change will affect you.
Exceptions
If you are or become pregnant during a specified transition period or require palliative care during a specified transition period, then you may be eligible to continue receiving ODB program coverage for the originator biologic for a limited period of time if you meet certain criteria.
This exception may not apply if the biologic is not indicated for use in palliative care and/or pregnant patients. Please consult your pharmacist or prescriber for more information.
Additionally, if you have a medical reason why you can’t switch to the biosimilar, your specialist, doctor or nurse practitioner may request an exemption for you that will be considered on a case-by-case basis through the Exceptional Access Program.
Exemptions will be considered for patients in certain clinical circumstances, such as if you have experienced a negative reaction to at least two biosimilars.
ODB Program coverage
| Drug | Originator biologic (Recipients must transition to the biosimilar version and recipients new to treatment must start on the biosimilar version) | Biosimilars funded under ODB | Indications (Transition for other indications that are approved on a case-by-case basis which may not appear on the below list also applies) |
|---|---|---|---|
| Adalimumab | Humira® |
|
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| Enoxaparin | Lovenox® |
|
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| Etanercept | Enbrel® |
|
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| Filgrastim | Neupogen® |
|
|
| Infliximab | Remicade® |
|
|
| Insulin aspart | NovoRapid® |
|
|
| Insulin glargine | Lantus® |
|
|
| Insulin lispro | Humalog® |
|
|
| Ranibizumab | Lucentis® |
|
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| Rituximab | Rituxan® |
|
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| Ustekinumab | Stelara® |
|
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| Denosumab | Prolia® |
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| Denosumab | Xgeva® |
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| Aflibercept | Eylea® |
|
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| Tocilizumab | Actemra® |
|
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| Omalizumab | Xolair® |
|
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Note: If there is a conflict between the information on this website and the Ontario Drug Benefit Formulary (Formulary), the Formulary prevails.
Originator biologics versus biosimilars
Biologics are medicines made from substances found in living things. They are often used to treat diseases such as:
- cancer
- immune system disorders
- diabetes
A biosimilar biologic drug is a highly similar but generally less expensive version of an originator biologic drug. When a company develops a new biologic drug (an originator), that company has the sole right to make and sell the drug for a certain period of time. After that period ends, other companies can start making their own version. The biologic drug that other companies make is the biosimilar drug.
Biosimilars are not identical to originator biologics. However, Health Canada conducts rigorous testing to ensure that biosimilars have a highly similar structure, are equally as safe, and have the same therapeutic effect as the originator biologic. Numerous studies show little to no difference in safety and efficacy when patients move to a biosimilar. Biosimilars have been used extensively in the European Union and all Canadian jurisdictions, with the exception of Manitoba, have implemented similar biosimilar policies to expand the funding of biosimilar medications.
Health Canada is responsible for ensuring the safety, efficacy, and quality of all drugs. For a biosimilar drug to be approved in Canada, Health Canada must find no meaningful differences in safety and effectiveness compared to the originator biologic. The biosimilars included in Ontario’s expanded biosimilars policy have all been approved by Health Canada and are already in widespread use.
Biologic medicines, including biosimilars, have improved the treatment of many disabling and life-threatening diseases. The transition to biosimilars will allow patients to continue receiving the same high-quality treatment, while allowing the government to:
- fund more new drug therapies
- encourage innovation in the health care system
- continue to support the delivery of better, more connected patient care
Process for switching
If you are using a biologic that is subject to the transition requirement.
- Make an appointment as soon as possible during the transition period, with your specialist, doctor or nurse practitioner. Your specialist, doctor or nurse practitioner is also receiving information about the transition requirement and may be reaching out to you.
- Discuss transitioning to the biosimilar with your specialist, doctor, nurse practitioner or pharmacist. Note that only your specialist, doctor or nurse practitioner will be able to write a new prescription for you.
- Your specialist, doctor or nurse practitioner will explain the transition process, discuss your options, write you a new prescription, and help enroll you in a patient support program, if applicable.
Infusion clinics
For ODB program recipients taking a biologic drug that is subject to the transition requirement at an infusion clinic, you may have to go to a new infusion centre to receive your infusion of the biosimilar drug.
The Ministry of Health has been working closely with its health care partners to ensure that ODB Program recipients who require an infusion have access to an infusion clinic that can deliver the biosimilar. Infusion clinics in Ontario are ready to support ODB program recipients with their transition to a biosimilar.
At home
For ODB program recipients who are self-administering their biologic product at home but who are affiliated with a patient support program, you may need to be enrolled in a new patient support program associated with the biosimilar you will be using.
Preventing the nocebo effect
The nocebo effect occurs when a patient’s negative expectations affect the treatment outcomes. A patient’s mindset can impact their perceived symptoms and their sense of well-being.
To combat against a potential nocebo effect, you can:
- acknowledge the nocebo effect
- inform yourself about biosimilars
- discuss biosimilars with your specialist, doctor, nurse practitioner or pharmacist and what it means for you
- keep a neutral or positive outlook
- stay informed about the switch process
Contact
For any questions about how this policy applies to you, please contact your specialist, doctor, nurse practitioner or pharmacist.
For more information about the biosimilar policy, please contact the Ontario Public Drug Programs by:
- email: DrugProgramsDelivery@ontario.ca
- phone:
416-327-8109 or1-866-811-9893 and pressing “1” for the Public Inquiries Officer
Footnotes
- footnote[1] Back to paragraph Humalog® 200 units/mL KwikPen® 200U/mL Inj Sol-Pref Pen 5x3mL Pk (DIN 02439611) is excluded from this funding policy regarding biosimilars as no biosimilar is available for this strength.