Current state of subsequent entry biologics (biosimilars) in Canada: a view from regulatory, reimbursement, clinician, and patient perspectives

Abstract

Biological molecules represent a significant portion of therapies utilized in Canada. Biosimilars, also known as subsequent entry biologics (SEBs) in Canada, are highly comparable versions of the originator products. Over the next few years, a number of patents for innovator biologicals will expire in Canada and this creates a tremendous opportunity for the entrance of SEBs. In Canada, SEBs must first be evaluated via Health Canada's SEB regulatory pathway. Following approval, SEBs must also be assessed for cost-effectiveness by the national health technology assessment agency, Canadian Agency for Drugs and Technologies in Health (CADTH) under the Common Drug Review (CDR) or pan-Canadian Oncology Drug Review (pCODR) processes. CDR and pCODR provide reimbursement recommendations to the provincial/federal public drug plans and cancer agencies. At the time of this writing, multiple SEBs have been approved by Health Canada. Although SEBs are approved after thorough evaluation by regulatory agency, there are concerns expressed by various medical communities, specifically regarding issues of indication extrapolation and interchangeability. The purpose of this paper is to provide a brief overview of the current status of SEBs in the Canadian context, as well as potential lessons that can be learned from European authority on SEBs.