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Biosimilar drugs will no longer need phase 3 clinical trials: Proposed changes from Health Canada

Photo of Paul JorgensenPhoto of Pardeep HeirPhoto of Kristin Wall
By Paul Jorgensen, Pardeep Heir & Kristin Wall on June 20, 2025

Health Canada has proposed a substantial change to the regulation of biosimilar drugs in Canada that may result in earlier applications for marketing authorization and earlier litigation under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations). Specifically…

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