In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, and market access) since our March 2023 update....more
On February 29, 2024, the Minister of Health announced the introduction of Bill C-64, An Act respecting pharmacare (Pharmacare Act), which “proposes the foundational principles for first phase of national universal pharmacare...more
On November 1, 2023, the Federal Court of Appeal (FCA) dismissed Actial’s appeal from an application for judicial review of the Minister of Health’s decision to disclose records pursuant to a request under the Access to...more
On May 26, 2023, the Minister of Health issued a decision that Biosimilar Collaborations Ireland Limited (BCIL) was entitled to the benefit of a notice of allegation (NOA) served by the previous owner of a new drug submission...more
On June 5, 2023, the Minister of Health released a statement on drug and other health product shortages, providing an update on actions being taken aimed at minimizing shortages and their impacts. ...more
As previously reported, the Federal Court quashed a second decision by the Minister of Health (Minister) to issue a Notice of Compliance (NOC) to Médunik Canada (Médunik) for its amifampridine product, RUZURGI, following the...more
On November 21, 2022, the Minister of Health tabled the 2021 Annual Report of the Patented Medicine Prices Review Board (PMPRB). The Report includes information on the PMBRB’s regulatory activities, pharmaceutical sales and...more
Le 22 septembre 2022, le ministre de la Santé, Jean-Yves Duclos, ainsi que la ministre de la Santé mentale et des Dépendances et ministre associée de la Santé, Carolyn Bennett, ont annoncé le lancement de l’examen législatif...more
On September 22, 2022, Canada’s Minister of Health, Jean-Yves Duclos, and Minister of Mental Health and Addictions and Associate Minister of Health, Carolyn Bennett, announced the overdue legislative review of Canada’s...more
On August 17, 2022, the Federal Court, per Justice Fothergill, dismissed AbbVie’s applications for judicial review of the Minister of Health’s decisions that (1) JAMP was not a “second person” and therefore it was not...more
Merck sought leave to appeal a decision of the Federal Court of Appeal (2021 FCA 224) affirming a Federal Court decision upholding Health Canada’s refusal to add a patent relating to a formulation of Merck’s KEYTRUDA, a...more
On March 30, 2022, the Minister of Health tabled the 2020 Annual Report of the Patented Medicine Prices Review Board (PMPRB). The 2020 Annual Report outlines the PMPRB’s mandate, structure and regulatory activities and...more
On April 14, 2022, the Minister of Health announced that the amendments to the Patented Medicines Regulations (the “Regulations”), originally released on August 18, 2019, would come into force on July 1, 2022 in a...more
As we have previously reported, in response to the COVID-19 pandemic, the Minister of Health had made interim orders pursuant to the Food and Drugs Act to address the significant risk to health posed by shortages in 2020 and...more
On March 10, 2022, for the second time, the Federal Court set aside a decision by the Minister of Health (Minister) to issue Médunik Canada (Médunik) a Notice of Compliance (NOC) for its amifampridine product, RUZURGI,...more
As previously reported, McHaffie J. of the Federal Court dismissed an application for judicial review brought by Canada RNA Biochemical (C-RNA), concluding that the Minister of Health (Minister) was reasonable in refusing to...more
On August 9, 2019, the Minister of Health denied Merck’s application for a Certificate of Supplementary Protection (CSP) for Canadian Patent No 2,670,892 relating to the drug suvorexant (Merck’s BELSOMRA). On September 29,...more
As previously reported, Apotex sought leave to appeal a decision of the Federal Court of Appeal (2021 FCA 52) affirming a Federal Court decision finding that the claims of a patent relating to lisdexamfetamine (Shire’s...more
On July 31, 2021, the Minister of Health provided notice of proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations. The amendments are planned for spring 2022 and are intended to modernize...more
Update: On November 10, 2021, the Minister rejected Janssen’s second request for data protection for SPRAVATO, which was submitted following the coming into force of the Canada-United States-Mexico Agreement (CUSMA). The...more
As previously reported, the Federal Court of Appeal dismissed Apotex’s appeal from a decision holding that the claims of a patent relating to lisdexamfetamine (Shire’s VYVANSE) were valid and prohibiting the Minister of...more
Update: On redetermination, Health Canada issued a new notice of compliance for RUZURGI on June 24, 2021. Catalyst and Kye have sought judicial review (Court File No T-1047-21). On May 31, 2021, the Federal Court quashed a...more
On May 18th, Christian Dubé, the Minister of Health and Social Services for Quebec announced that the government will begin a shift in favor of the use of biosimilar drugs. The announcement stated that similar to other...more
In the first appellate decision relating to Certificates of Supplementary Protection (CSPs), the Federal Court of Appeal has allowed the appeal of the Minister of Health (the Minister), setting aside the lower court judgment....more
As previously reported... on September 16, 2020, Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the ISAD Interim Order), which...more