Food, Drugs, Healthcare, Life Sciences

As science evolves, policies may evolve as well. But when policy changes affect how a decision-maker exercises their discretion, those decision-makers must explain why they are taking a new approach.

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.

For many Canadians, vacation time means escaping the cold, and for some, that also means enjoying a drink or two.

As science evolves, policies may evolve as well. But when policy changes affect how a decision-maker exercises their discretion, those decision-makers must explain why they are taking a new approach.

On June 10, 2025, Health Canada launched a consultation on its Draft Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs...

You may have seen this article or some other article yesterday or today, covering the Ontario Supreme Court's recent certification of...

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.

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.

Le 10 juin 2025, Santé Canada a publié une ébauche des nouvelles « Lignes directrices : Exigences en matière de renseignements et de présentation relatives aux médicaments biologiques biosimilaires...