Biosim•Exchange

Canada’s trusted source for timely information on biologic biosimilars

The Biosim•Exchange provides research-based information on biosimilar safety and effectiveness to inform consumers and patients and report on public and private health insurance formulary policy or listing decisions.

Our aim with the development and timely delivery of biosimilars information is to help patients better understand what they are and learn about their place among other treatments. Armed with this knowledge, patients and their physicians can build stronger partnerships leading to improved shared decision-making and treatment plan results.

Request a Patient Guide on Biosimilars in Canada

What is a Biosimilar?

What is a Biosimilar?

A biosimilar is a biologic medicine that has similar effectiveness, safety and quality, and delivers the same therapeutic benefits to patients as its reference biologic “originator”. Biosimilars have been approved for use in Canada since 2009. There are 14 biosimilars currently approved by Health Canada.

What is a Biosimilar?

Quality & Safety Around Biosimilars

Quality and Safety Around Biosimilars

Patients and healthcare professionals can be confident when using a biosimilar approved by Health Canada.

Health Canada has strict, science-based regulatory controls and testing requirements around biosimilars. In fact, all biosimilars authorized in Canada meet the same high standards for quality, safety and efficacy as originator biologic medications.


Transitioning to a biosimilar is safe and effective

Transitioning to a Biosimilar Is Safe and Effective

The leading regulators in the world, including Health Canada, support well-controlled transitions from an originator to a biosimilar biologic.

Transitioning to a biosimilar starts with a conversation between a patient and their doctor.

Biosimilars Education Videos

What are biosimilars?

Transitioning between biologic originators and biosimilars

The societal benefits of biosimilars

The rheumatologist – patient biosimilars transition conversation

Helping patients manage the transition between similar biologic medications

Frequently Asked Questions About Biosimilars


1. What is a biosimilar?

A biosimilar is a biologic medicine that has similar effectiveness, safety and quality, and delivers the same therapeutic benefits to patients as its biologic “originator”. Biosimilars have been approved for use in Canada since 2009. There are 14 biosimilars currently approved by Health Canada.

2. What is a biologic?

Biologics are life-saving medications made from living organisms, such as living cells that have been modified using biotechnology. This allows these living organisms or cells to produce the active substance of the biological medicine.

3. Are biosimilars as safe and effective as their biologic originators?

Yes. There are no clinically meaningful differences in safety and efficacy between biologic biosimilars and their originator. There may be small variances. In fact, there are even variances between different production batches of the same originator biologic medicines. Biosimilars deliver the same therapeutic benefits to patients as their biologic originators.

4. Are biologic biosimilars different from generic medications?

Biosimilars are not the same as generic medications as biologics cannot be exactly copied. A biologic biosimilar and its originator can be shown to be highly similar, but not identical. Biosimilars like generic medications are produced when an originator loses its patent and are lower priced. There are no clinically meaningful differences in safety and efficacy between biologic biosimilars and their originator.

5. How are biosimilars regulated?

Health Canada has strict, science-based regulatory controls and testing requirements around biosimilars. In fact, all biosimilars authorized in Canada meet the same high standards for quality, safety and efficacy as other biologic medications.

6. Can a patient already being treated with a biologic originator be transitioned to a biosimilar?

The leading regulatory bodies, including Canada’s, supports well-controlled transition.

Health Canada recommends that a decision to switch a patient being treated with an originator biologic medication to a biosimilar, or between any biologics, be made by the treating physician in consultation with the patient and take into account any policies of the relevant jurisdiction.

7. Where can patients get more information about biosimilars?

  • Your rheumatologist or rheumatology nurse
  • Public or private drug plan websites
  • Scientifically reviewed and trusted websites of credible patient organizations such as the Biosim•Exchange website by the Arthritis Consumer Experts.
Frequently Asked Questions About Biosimilars

The Benefits of Biosimilars

Biosimilars represent an opportunity to significantly reduce government healthcare costs, while improving patient care.

1. Biosimilars are next-generation biologic medications

After a biologic originator’s patent expires, other medication manufacturers can produce their own biosimilar version of it. Biosimilars can improve access to biologics to people living with chronic diseases and produce significant savings for healthcare systems and patients.

2. Biosimilars broaden access to effective biologic treatments

Biosimilars will enable more patients to have access to other life-saving treatments.

3. Biosimilars are a part of a sustainable health care system

Biosimilars present an opportunity to provide next-generation biologic therapy and reduce health care costs for patients and our health care system.

The Benefits of Biosimilars
Learn More

Learn More

Health Canada factsheet on biosimilars

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Health Canada information centre on biosimilars

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More facts on biosimilars from ACE

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Arthritis Research Canada on biosimilars

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Who We Are

Who We Are

Arthritis Consumer Experts (ACE) is Canada’s largest arthritis patient organization that provides science-based information and education programs to people with arthritis. ACE has been a leader in biosimilar discussions since 2009, sharing information with stakeholders across Canada through free research-based workshops, webinars and education programs.

ACE supports Canadians living with all forms of arthritis by helping them take control of their disease and improve their quality of life. ACE is guided by a transparent set of guiding principles, set out by an advisory board comprised of leading Canadian scientists, medical professionals and informed arthritis consumers.

The information on this webpage has been scientifically reviewed by Arthritis Research Canada (ARC). This site complies with the HONcode standard for trustworthy health information.