Biologics and Biosimilars Available in Canada

Background on Biologics and Biosimilars

Biologics are large, complex medicines that are made in living cells.¹ In comparison to small molecule drugs, such as Aspirin®, which have simple molecular structures and can be ingested in pill form, biologic medicines must be injected or infused into patients to avoid digestion of their intricate protein structure in the gastrointestinal tract.² Many of the biologic therapies available that have revolutionized the treatment of inflammatory diseases in recent years target and block inflammatory cell signalling molecules (cytokines) and immune cells.³

Upon patent-expiry of an innovative small molecule drug, an exact copy of its simple structure can be created by other companies resulting in a generic version of the drug.^2,4 The generic version is deemed bioequivalent to the brand name as it is created using the same, relatively simple chemical recipe. In contrast, biologic medicines are large proteins requiring many intricate steps in their production in living cells using complex biotechnology processes. As such, it is not possible to create an exact, identical copy or “generic” version of the originator biologic upon expiry of patent, therefore these medicines are termed biosimilar.

Health Canada requires biosimilar manufacturers to provide information demonstrating that the biosimilar is safe, effective, and highly similar to the reference originator biologic.^4,5 Given that Health Canada is assessing the similarity of the biosimilar to the originator biologic, the type of data required to support authorization of the biosimilar is different from that of an originator biologic. The structure and function of the biosimilar are assessed, in addition to human clinical studies in patients new to biologic therapy, to confirm that there are no clinically meaningful differences in safety and efficacy between the biosimilar and originator biologic.^4,5

Summary: Biologic therapies currently available in Canada

The following list of originator biologics and biosimilars are indicated for the treatment of inflammatory bowel disease, primarily Crohn’s disease and ulcerative colitis.

For a complete list of biosimilars for various diseases and disorders, go to Health Canada’s product database, checkmark Biosimilar Biologic Drug under “Search by other criteria” and click Search. This will generate the most up to date list of biosimilar products that Health Canada has reviewed. Note that this search will not include originator biologics.

1. Indicated for children 13 to 17 years old, weighing more than 40 kg (88 lbs), with severe disease and have failed conventional and/or some biologics.
2. Not for use for children less than 9 years of age.
3. Not for use for children less than 6 years of age.
4. Indicated for children 5 years of age and older, with moderate to severe disease and have failed conventional therapies (e.g., corticosteroids and immunosuppressants).

Please note that this may not be a complete list and may be subject to changes.

What is Health Canada saying?

Health Canada does not consider biosimilars to be identical or bioequivalent to their originator reference biologic and states that biosimilars are not the same as generic drugs.^4,6  However, approved biosimilars are safe, effective, and highly similar to the reference originator biologic and there are no clinically meaningful differences in safety and efficacy between them in patients newly started on biologic therapy.

Health Canada recommends that any decision to switch a patient from an originator biologic drug to its biosimilar should be made by the physician in consultation with their patient, taking into account the clinical evidence available as well as any prescribing policies in the relevant jurisdiction.^4,6

Want to learn more about biologics and biosimilars? Click here.

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Ganive Bhinder, BSc, PhD

1. Strand, V. et al. Biologic therapies in rheumatology: lessons learned, future directions. Nature Reviews Drug Discovery. 2007(6):75-92
2. Morrow, T. et al. Defining the difference: what makes biologics unique. Biotechnology Healthcare. 2004(4):24-26
3. Alon, D. et al. Mechanism of action of Anti-TNF therapy in inflammatory bowel disease. Journal of Crohn’s and Colitis. 2016(10):989-997
4. Health Canada: Fact Sheet on Biosimilars (updated 2017-08-13). https://www.canada.ca/content/biosimilars
5. Health Canada Guidance Document. Information and Submission Requirements for Biosimilar Biologic Drugs. 2016 https://www.canada.ca/content/
6. Biosimilar Drugs: Health care provider hand-out. CADTH online document. (updated 2017-03-09). https://cadth.ca/biosimilar_drugs

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