PHP138 - CANADIAN PUBLIC REIMBURSEMENT OF BIOSIMILARS (REFERRED TO AS SUBSEQUENT ENTRY BIOLOGICS – SEBS – IN CANADA), AN UPDATE

Abstract

i) to provide an update on the current status of SEBs in Canada as assessed by the Common Drug Review (CDR) evaluative process of the Canadian Agency for Drugs and Technologies in Health; ii) to illustrate the Canadian Drug Expert Committee recommendations for newly recommended SEBs and how the recommendations compare with regulatory approval; iii) to display the timelines associated with negotiations conducted by the pan-Canadian Pharmaceutical Alliance (pCPA) following the CDEC recommendation; iv) if possible (depending on timing of listings) to highlight how the public reimbursement of SEBs compare with that of the reference products (particularly Inflectra vs. Remicade); and v) to highlight potential issues that may have arisen from the entry of SEBs in Canada. Information was retrieved from CDR, pCPA, public plans, and Health Canada websites. As of this abstract, two new SEBs (Apotex’s Grastofil [ref. Neupogen]; and Eli Lilly’s Basaglar [ref. Lantus]) are under review at the CDR. The first monoclonal antibody SEB Inflectra completed pCPA negotiation at end of 2015. Reimbursement decisions by public plans are expected to follow shortly. At least one non-monoclonal antibody SEB approved by Health Canada lacked comparative phase III clinical studies is being evaluated by the CDR. The review of Inflectra illustrated some important issue. First, the CDR recommendations were in line with indications granted by Health Canada. This could mean that the CDR is not comfortable going beyond the Health Canada labelling. Second, the pCPA review took much longer than the CDR review, which may indicate that a 31% price drop is not sufficient to yield substantial cost savings beyond the confidential Product Listing Agreements (PLAs) already in place for established biologics. More SEBs are entering the Canadian market. The assessments, recommendations and listings of these products will start to increase in number and will be of great interest.