Biosimilar biologic drugs

Organization: Health Canada

A biosimilar is a biologic drug (biologic) that is highly similar to another biologic previously authorized for sale. The biologic that is already authorized for sale is called the reference biologic drug.

A biosimilar is approved by Health Canada based on a thorough comparison with its reference biologic drug demonstrating that there are no clinically meaningful differences in efficacy and safety between them.

Biologics are made from living organisms or their cells, often using biotechnology. Some examples include insulin, growth hormones, and antibodies. Among other things, biologics can be used to treat:

• diabetes
• hormone deficiency
• rheumatoid diseases
• some forms of cancer
• bowel diseases
• retinal diseases

Health Canada expects no differences in how you respond to treatment should you change from a reference biologic drug to its biosimilar. This is because of the highly similar nature of a biosimilar to its reference biologic drug.

Health Canada authorizes biosimilars for sale using the same rigorous regulatory standards for quality, efficacy and safety as for all other biologic drugs. In addition, Health Canada continues to monitor the safety of all health products for sale in Canada after their approval, including biosimilars.

Please visit the Biosimilar biologic drugs in Canada: Fact Sheet for more information on biosimilars in Canada