The pan-Canadian Pharmaceutical Alliance (pCPA) and Cancer Care Ontario have partnered to create a pan-Canadian Oncology Biosimilars Initiative, which aims to ensure appropriate implementation and cost-effective use of therapeutic oncology biosimilars across Canada. In November 2018, the Initiative held a Pan-Canadian Oncology Biosimilars Summit. The Initiative has released a Proceedings Report of the Summit, as well as a pan-Canadian Oncology Biosimilars Initiative Action Plan.
Separately, Health Canada announced that it is collaborating with the Drug Safety and Effectiveness Network on a project studying patients with inflammatory rheumatic diseases and inflammatory bowel disease who are taking biologic drugs, aiming to compare the safety and effectiveness of biosimilar drugs to the reference biologic drug. The protocol for the study can be found here.
Related Publications & Articles
-
Health Canada consultation on two draft guidance documents on terms and conditions for human and veterinary drugs and drug submissions based on promising evidence of clinical efficacy
As previously reported, in December 2024, Health Canada published its agile licensing amendments to the Food and Drug Regulations.Read More -
2025 highlights in Canadian life sciences IP and regulatory law
In 2025, the Rx IP Update team at Smart & Biggar reported on a number of developments in Canadian life sciences IP and regulatory law.Read More -
Proposed Ministerial Reliance Order would allow Health Canada to rely on decisions of foreign trusted regulators
On December 19, 2025, the Minister of Health announced the launch of consultations on two key regulatory initiatives referenced in Health Canada’s Red Tape Review report: (i) the Ministerial Reliance ...Read More
