With a number of biosimilars expected to launch in Canada in 2019 and beyond, Canadian organizations are collaborating to improve biosimilar adoption. Canada lags behind the European Union in terms of approval and uptake of biosimilars [1].
In the first of two recent developments, Cancer Care Ontario and the pan-Canadian Pharmaceutical Alliance have partnered to form the pan-Canadian oncology biosimilars initiative. This initiative aims to ensure the appropriate implementation and cost-effective use of therapeutic oncology biosimilars across Canada. Three oncology biosimilars are expected to launch in Canada in the near future: bevacizumab and trastuzumab (both expected in the third quarter of 2019), and rituximab.
The initiative held a summit in November 2018, the Pan-Canadian Oncology Biosimilars Summit, which included patients, patient advocacy groups, clinicians, health system administrators and government officials from nine provinces. At the summit, Cancer Care Ontario and the pan-Canadian Pharmaceutical Alliance presented draft strategic objectives and requested that the participants provide feedback on them. The feedback was used to inform an action plan for facilitating the adoption of oncology biosimilars.
The action plan calls for ongoing stakeholder engagement; developing standard procedures for the prescribing, storing, preparing, labelling, dispensing and administering of oncology biosimilars; addressing the technical and logistical challenges to adopting best practices; developing clear guidance on clinical scenarios such as initiating, switching and generalizability; patient monitoring and evaluation of safety and efficacy including real-world evidence and patient-reported outcomes; developing reimbursement strategies that promote implementation; and reinvestment of savings from use of biosimilars. Many of the themes within this action plan echo the recommendations published by a Canadian breast cancer advocacy group in April 2019, which were based on insights collected from roundtable discussions with patients and medical oncologists [2, 3].
Health Canada has announced a collaboration with the Drug Safety and Effectiveness Network to study patients with inflammatory rheumatic disease and inflammatory bowel disease (IBD) who are using biological drugs in Canada, with the aim of comparing the safety and effectiveness of biosimilars with reference biological drugs. The study will focus primarily on patients without previous biological drug use, but also include patients switching to a biosimilar from a reference biological drug. This 5-year study will assess the length of time patients remain on treatment, whether their disease control improves, whether they require a different treatment, and the incidence of adverse events that could be related to biosimilar use. Adult patients are currently being recruited from IBD and rheumatology cohorts, and retrospective data is being analysed.
These two developments follow Health Canada’s recent decision on naming convention for biologicals [4].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 17]. Available from:www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada
2. GaBI Online - Generics and Biosimilars Initiative. Patient and provider views on biosimilars to treat breast cancer [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 17]. Available from:www.gabionline.net/Biosimilars/General/Patient-and-provider-views-on-biosimilars-to-treat-breast-cancer
3. GaBI Online - Generics and Biosimilars Initiative. Recommendations published by Canadian breast cancer advocacy group [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 17]. Available from: www.gabionline.net/Biosimilars/General/Recommendations-published-by-Canadian-breast-cancer-advocacy-group
4. GaBI Online - Generics and Biosimilars Initiative. Health Canada announces naming convention for biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 17]. Available from:www.gabionline.net/Policies-Legislation/Health-Canada-announces-naming-convention-for-biologicals
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