Biosimilar Initiative

Information for Patients

Frequently Asked Questions 

What is a biologic?

Biologic drugs (originators and biosimilars) are made using living organisms (e.g., yeast or animal cells) rather than being synthetically manufactured. This class of drugs is designed to treat various conditions by affecting certain processes within the body.

What is a biosimilar?

As patents and data protection expire for originator (brand names) medicines, other manufacturers may produce new versions of the biologic medicines called biosimilars.

To receive Health Canada’s authorization to be used and sold in Canada, a biosimilar must demonstrate it is highly similar and has no clinically meaningful difference in efficacy and safety compared to an original brand.

Biosimilar biologics are not identical to originator biologics due to their complex structure. However, biosimilars are highly similar to the originator and are tested to ensure the same health outcomes and level of safety.

Are biosimilars safe?

Health Canada is responsible for ensuring the safety, efficacy, and quality of all new drugs including biologics (originators and biosimilars). Before a biosimilar drug can be approved in Canada, Health Canada must have found no meaningful differences in safety and effectiveness compared to the originator version. The biosimilars involved in the Biosimilars Initiative have all been approved by Health Canada.

What is “switching”?

For the past three years, provincial drug plans across Canada have listed biosimilar brands ahead of original-brand biologics for patients who have not previously received the original-brand biologic. In the past year, some provincial drug plans have begun implementing “switch” policies that change coverage for specific biologic medicines.

Under these policies, patients and their prescribers have a certain period to discuss switching from an originator brand to a biosimilar brand.

In the context of biosimilar use, Health Canada considers switching from an originator biologic to a biosimilar to be a change from one routine to another routine.  Patients and healthcare providers can have confidence that biosimilars are effective and safe for each of their authorized uses (indications).

Do I have to switch to a biosimilar?

Yes. If you are covered by one of GNWT’s supplementary health benefit programs and using any of the originator biologics in Table 1: List of Current Originator Biologics and the corresponding Biosimilars eligible for coverage. You will need to switch to the biosimilar version before the end of the switch period, June 20, 2022, in order to avoid any disruption to your coverage.

What if I have private coverage?

If you do not rely on the GNWT’s supplementary health benefit programs for coverage of your originator biologic, the Biosimilars Initiative will not directly affect you. However, as some private insurers offering employer-sponsored plans have also been implementing biosimilar switch policies, you may wish to contact your insurer for more information.

What if I can’t switch to a biosimilar?

Patients who are unable to switch for medical reasons may have their prescriber submit an Exception Request for coverage of the originator drug.

In the request, the prescriber must clearly identify why the patient is unable to switch and evidence that all biosimilar drug products have been tried prior to the request being made. These requests are considered on a case-by-case basis.

Will a biosimilar work for me?

Though a biosimilar biologic is not identical to an originator biologic, there are no clinically meaningful differences between them. A biosimilar drug delivers similar effectiveness, level of safety, and the same therapeutic benefits to patients. Health Canada assures patients and health professionals that biosimilars are safe and effective. Health Canada expects no differences following a change in routine use between an originator and its biosimilar for diseases they are approved to treat.

Ask your prescriber about your options based on your medical history and what the differences are between the available medications.