Canada: Life Sciences, Biotechnology & Nanotechnology

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Health Canada Finalizes Biosimilar Guidance: Comparative Clinical Efficacy Studies Not Typically Required
In Canada, biosimilar products are approved by way of a new drug submission, following Health Canada guidance first released in 2010 and significantly revised in 2016. Such guidance had, in most cases, required comparative clinical efficacy and safety trials between the biosimilar and reference product. In 2025, Health Canada consulted on a revised draft guidance document for biosimilar submissions, which notably proposed removing the requirement for comparative clinical efficacy and safety trials.
Canada Healthcare
SB
Smart & Biggar
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