Handbook for health care professionals on biosimilar biologic drugs: Overview 

Disclaimer: Health Canada developed this handbook to inform and educate health care professionals in Canada on biosimilars. This handbook was developed in consultation with a working group composed of subject matter experts from Health Canada and external health care professionals representing a range of professional associations. Nevertheless, the views expressed in this handbook are those of Health Canada and do not necessarily reflect the views of the external health care professionals who were part of the working group.

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A biosimilar is a biologic drug that's highly similar to a biologic drug already authorized for sale. It's known as the reference biologic drug, or the originator product.

Unlike generic drugs, biosimilars can never be identical to their reference biologic drug, simply because they're isolated from or manufactured in living organisms. However, they have been demonstrated to have no clinically meaningful differences in efficacy and safety compared to the reference biologic drug.

Health Canada authorizes biosimilars according to the same regulatory standards of quality (chemistry and manufacturing), safety and efficacy that apply to all biologic drugs authorized in Canada.

A biologic drug is authorized on the basis of quality, non-clinical and clinical data. A biosimilar is authorized based on a demonstration of similarity as a complete new drug submission, using studies that compare them to their reference biologic drug. These studies include comparative physicochemical, structural and functional properties, and may also include comparative non-clinical, pharmacokinetic/pharmacodynamic (PK/PD) and clinical studies as needed. Once similarity is established, the evidence used to support the authorization of the reference biologic drug is applied to the biosimilar's authorization.

Health Canada can grant indications to the biosimilar based on the efficacy and safety of the reference biologic drug. The biosimilar may be granted all or only some of the indications based on a number of criteria. This is called an extension of indications.

Health Canada's authorization of a biosimilar is not a declaration of equivalence to the reference biologic drug. This is because the biosimilar is highly similar but is not identical to its reference biologic drug. Only provinces and territories can deem that 2 products are interchangeable, according to their own rules and regulations.

Once marketed, Health Canada monitors the safety of each biosimilar using the same pharmacovigilance activities used for all drugs.

In 2010, Health Canada released the following guidance document:

This guidance outlines the requirements for the authorization of safe and effective biosimilar drugs. A revised guidance, released in 2016, reflects experience gained over time. International experience over a number of years has shown no notable differences in safety and effectiveness between biosimilars and their reference biologic drugs.

Health care professionals play a vital role in:

Acknowledgements and contributors

Health Canada's Biologic and Radiopharmaceutical Drugs Directorate prepared this handbook with valuable input from a working group composed of in-house scientific evaluators and representatives from the Marketed Health Products Directorate and Strategic Policy Branch.

Also providing input were the following health care professionals from a wide range of professional associations:

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