An Ever-Evolving Landscape: an Update on the Rapidly Changing Regulatory and Reimbursement of Biosimilars in Canada

Category: Review Article
Author(s): , , , ,
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Keywords: biosimilars, CADTH CDR, CADTH pCODR, Health Canada, INESSS, pCPA
Abstract:
Since the introduction of the first infliximab biosimilar, Inflectra, significant changes have taken place in the Canadian biosimilar landscape, and both the regulatory and the reimbursement processes have been streamlined. Biosimilars must first receive regulatory approval by Health Canada. The Canadian Agency for Drugs and Technologies in Health (CADTH) used to evaluate biosimilars for public payers outside Québec, but they do not do so anymore.  The Institut National d’excellence en Santé et en Services Sociaux (INESSS) will still review biosimilars in Québec, but they are expected to use an expedited process so as not to create any delays. Once the public reviews have been completed, the pan-Canadian Pharmaceutical Alliance (pCPA) will negotiate pricing, which will be transparent. The province of British Columbia became the first public jurisdiction in Canada to mandate switching from originators to biosimilars. The processes for private plan reimbursement are less complex. The changes that have been instituted work to ensure the sustainability of the Canadian healthcare system, by promoting faster and greater uptake of the lower-cost biosimilars, while ensuring high quality biologic treatments remain accessible to patients. Furthermore, attitudes of Canadian physicians and patients have shifted towards the acceptance of biosimilars. The purpose of this paper is to provide an update on the current status of biosimilars in the Canadian context.

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