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Canada Biosimilars Regulatory Reform

Stikeman Elliott LLP

Canada Reconsiders Comparative Clinical Trials Requirements for Biosimilars

Stikeman Elliott LLP on

On June 10, 2025, Health Canada initiated a public consultation on proposed revisions to its Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. A notable update is the proposal to remove...more

Smart & Biggar

Update on biosimilars in Canada – June 2025

Smart & Biggar on

This article provides an update on developments in the biosimilar space in Canada—regulatory, approvals, pending submissions, litigation, and market access—since our March 2024 update. Consultation on revised biosimilar...more

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