Biosimilar medicines are versions of original-brand biologics that have lost patent protection.

To receive Health Canada's authorization, a biosimilar must demonstrate that it is highly similar and has no clinically meaningful differences in efficacy and safety compared to an original-brand biologic.¹

Because biosimilar manufacturers must perform comparative studies to demonstrate similarity, the type of data required to support biosimilar authorization differs from that required for an original-brand biologic medicine.²

Biosimilar medicines are not the same as the more common generic medicines, which contain identical medicinal ingredients to their original-brand products.

A biosimilar and its original-brand biologic medicine can be shown to be highly similar, but not identical. This is because biologic medicines:

• are often large and complex
• are made from living cells rather than with chemicals and so are naturally variable

Compared to generics, more studies are needed for the regulatory approval of a biosimilar in order to demonstrate that it is highly similar to its original-brand biologic medicine.

After a medicine is authorized for sale, post-market analyses and studies can further demonstrate no meaningful differences in clinical efficacy and safety between a biosimilar and the original-brand biologic.³

Since 2009, Health Canada has authorized 37 biosimilars of 15 original-brand medicines.⁴

The key principles Health Canada uses to evaluate biosimilars align with those of other regulators and international organizations⁵ such as the:

• European Medicines Agency (EMA)
• United States Food and Drug Administration (FDA)
• World Health Organization (WHO)

Health Canada's position on the use of biosimilars is consistent with the International Coalition of Medicines Regulatory Authorities (ICMRA), a coalition of regulators from 29 regulatory authorities across the world,⁶ including:

• Australia
• The United States
• the United Kingdom and
• the European Union

In July 2019, the ICMRA issued a statement on biosimilars, providing assurance on the regulatory processes for the approval and monitoring of biosimilars medicines and highlighting the benefits they can provide for patients and healthcare systems in terms of increased treatment alternatives, access and cost competitiveness.⁷

For more information about biosimilars, please read Health Canada’s Biosimilars Fact Sheet.