Biosimilars in the Canadian market


Before they can be approved by Health Canada, biosimilars have to go though an extremely thorough authorization process based on how similar they are to their reference biologic drug. Showing this similarity involves many steps, beginning with structural and functional studies, and moving on to human studies. Teva Canada is committed to making sure that any biosimilar we manufacture is made in state-of-the-art facilities with the highest-quality agents.


Regulatory pathways of originator biologics vs. biosimilars

Originator development, demonstrate safety, purity and potency clinical studies (safety, efficacy, immunogenicity) (PK/PD) In vido studies (non-clinical) in vitro studies (analytical characterization) Biosimilar develoment - demonstrate biosimilarit to the reference product.  


As biosimilars continue to grow in importance within the Canadian market, they are predicted to contribute to the sustainability of the healthcare system via:

ICON_reduced_cost_blue.png Reduced cost

Biosimilars typically cost less than their reference biologics.

ICON_increase_competition_blue.png Increased competition

Biosimilars introduce competition, which in turn may also help reduce costs.

ICON_improved_drug_accessibility_blue.png Improved drug accessibility

Savings from biosimilars could be put towards funding for other much-needed therapeutic areas.

Understanding biosimilars

Dive deeper into the facts about Biosimilar.

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Teva's commitment to biosimilars

When it comes to Biosimilars, you can trust in Teva as a key partner.

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Biosimilar Drugs: your questions answered

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