Biosimilars Initiatives by Region
What is a Biosimilar?
A biosimilar is a drug proven to be highly similar to a biologic drug that has been authorized for sale in Canada (known as the reference or originator biologic drug).
Biosimilars have been approved by Health Canada based on a thorough comparison to a reference biologic drug and may enter the market after the reference biologic drugs’ patents and data protection has expired.
Biosimilar products first entered the Canadian market in 2009. Health Canada has already approved 15 biosimilars including 3 anti-TNF therapies: INFLECTRA® (inflixmab), and RENFLEXIS® (infliximab) with HADLIMA® (adalimumab), which is not commercially available in Canada.
Quality and Safety Around Biosimilars
To be approved in Canada, a biosimilar must be proven to have no clinically meaningful differences to the reference biologic. This means, studies of the biosimilar MUST show that there are no differences in outcomes for patients taking a biosimilar, compared to those taking a reference biologic drug.
Rigorous standards for authorization by Health Canada mean that patients and health care providers can have the same confidence in the quality, safety and efficacy of a biosimilar.
Transitioning to a Biosimilar is Safe and Effective
Health Canada supports switching from a biologic to a biosimilar and considers that a one-time switch from a reference biologic drug to a biosimilar to be acceptable. Health Canada also recommends that the decision to switch be made by the physician/prescriber and patient, taking into account any policies of the relevant jurisdiction.
Have you already been switched/transitioned to a biosimilar version of Remicade® (infliximab)?
- Canadian Originator Biologics Coalition
- Biosimilars Working Group
- Crohn’s and Colitis Canada
- Biosim Exchange
- CADTH Biosimilar Drugs | Fact Sheet
- Health Canada, Biosimilar Biologic Drugs in Canada | Fact Sheet
- Government of Canada | Guidance Documents: Information and Submission Requirements for Biosimilar Biologic Drug