Update: The comparison chart was last updated September, 2020.
As more biosimilars continue to be approved across the world, it is helpful to compare the applicable regimes across major jurisdictions. We have collaborated with Brian Coggio of Fish & Richardson, and Mary Foord-Weston and Camilla Balleny of Carpmaels & Ransford to prepare the chart below comparing relevant considerations for biosimilars in Canada, the US, and Europe, including regulatory pathways, data protection and patent linkage.
Related Publications & Articles
-
Release of Statistical Report 2023/2024 for PMNOC Regulations, data protection and CSPs
On August 12, 2024, the Office of Patented Medicines and Liaison of Health Canada released its Statistical Report 2023/2024 for the Patented Medicines (Notice of Compliance) Regulations, Data Protecti...Read More -
Boehringer Ingelheim succeeds in nintedanib PMNOC action against JAMP
In a public decision dated August 8, 2024, Justice Furlanetto of the Federal Court found Boehringer Ingelheim’s Canadian Patent No. 2,591,083 (the 083 patent) valid and infringed by JAMP in an action ...Read More -
PM(NOC) Regulations: seven-year anniversary of major amendments
September 21, 2024, marked the seventh anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activiti...Read More