News & Analysis as of

New Guidance Canada Biologics

Stikeman Elliott LLP

Canada Reconsiders Comparative Clinical Trials Requirements for Biosimilars

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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

Consultation open on Health Canada’s proposal on agile licensing for drugs and medical devices

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UPDATE: The consultation period has been extended until April 26, 2023. On December 17, 2022, the proposed amendments to both regulations were published for consultation: Regulations Amending Certain Regulations Made Under...more

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Rx IP Update - February 2019

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Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...more

Smart & Biggar

Rx IP Update - December 2016

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Janssen seeks leave to appeal to SCC regarding FCA decision upholding Minister of Health’s decisions relating to administrative drug submissions - As reported previously, on October 12, 2016, the Federal Court of Appeal...more

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