Canada: Food, Drugs, Healthcare, Life Sciences

On June 10, 2025, Health Canada issued a draft of the new "Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs...

TheraPsil, a patient advocacy organization, and 73 healthcare practitioners (HCPs) have succeeded in the Federal Court of Appeal (FCA) to overturn the refusal of the Minister of Mental Health...

After the tariff frenzy of the first quarter of this year, we've sailed into the doldrums. Not that the tariffs have gone away, or the threat of new ones has subsided, or there is a solid prospect...

TheraPsil, a patient advocacy organization, and 73 healthcare practitioners (HCPs) have succeeded in the Federal Court of Appeal (FCA) to overturn the refusal of the Minister of Mental Health...

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.

In the Patented Medicine Prices Review Board (PMPRB)'s June 2025 NEWSletter, Acting Chairperson Anie Perrault confirms that the PMPRB plans on publishing its final Guidelines in summer 2025.

On June 10, 2025, Health Canada issued a draft of the new "Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs...

Eli Science Inc. ("Eli Health"), a Montreal-based startup, has secured C$17 million in Series A funding to launch its at-home hormone monitoring technology.

Bill 15, also known as the Infrastructure Projects Act (the Act), received Royal Assent on May 29, 2025. The Act aligns with legislative efforts across Canada to implement streamlining processes intended to expedite...

On June 8, 2012, Genentech’s lawsuit seeking a declaration that US Patent No. 6,733,752 was invalid and not-infringed by Genentech’s trastuzumab product (HERCEPTIN).

Health Canada specifically contemplates certain proteins as SEBs in its Guidance, although Health Canada has not limited SEBs to only particular classes of drugs.

On May 23, 2012, the Federal Court held that Merck Frosst Canada Ltd. ("Merck") is liable to Apotex Inc. ("Apotex") for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the "Regulations"), but exercised its discretion to reduce the amount of compensation payable based on a defence of ex turpi causa.