Canadian Organizations Collaborate on Oncology Biosimilars Initiative

With additional biosimilars expected to reach the market later this year and beyond, Canada has made another move to foster biosimilar adoption with 2 recent developments.

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 released a report of the summit as well as an action plan.

Feedback from the summit informed the action plan, which lays out what will be required in order to facilitate the adoption of oncology biosimilars. There are 3 therapeutic oncology biosimilars that are expected in Canada during the next few years: bevacizumab, which references Avastin; trastuzumab, which references Herceptin; and rituximab, which references Rituxan. Bevacizumab and trastuzumab are expected to become available in the third quarter of 2019.

The plan calls for engaging stakeholders throughout the process; addressing the logistical and technical challenges to adopting best practices and standardized approaches to prescribing, storing, preparing, labelling, dispensing, and administering oncology biosimilars; developing reimbursement strategies that promote implementation; creating clear guidance on clinical scenarios such as initiating, switching, and generalizability; reinvesting savings from oncology biosimilars; developing an evaluation and monitoring plan that includes the collection and generation of real-world evidence, including patient-reported outcomes and the net value of biosimilar adoption.

As with the United States, Canada lags behind the European Union in terms of number of biosimilars approved and uptake of these products.

In the second development, Health Canada announced that it is collaborating with the Drug Safety and Effectiveness Network (DSEN) 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 DSEN was established in 2009 as a partnership between the Canadian Institutes of Health Research and Health Canada to examine issues related to affordability, accessibility, and appropriate use.

The Canadian Network for Advanced Interdisciplinary Methods for comparative effectiveness research (CAN-AIM) team, which is part of the DSEN, is undertaking this work.

CAN-AIM will study patients across Canada; the primary focus is on patients without a previous history of biologic drug use. CAN-AIM will also study patients switching to a biosimilar drug from a reference biologic drug.

The 5-year study will measure how long patients stay on treatment, whether they require new treatment, whether their disease control improves, and the occurrence of adverse reactions that could be related to these drugs.

Adult patients are currently being recruited from both rheumatology and IBD cohorts and retrospective data is being analyzed.