Infliximab reference product versus biosimilar for the treatment of rheumatoid arthritis : scoping report

As patents for first-to-market biologics expire, subsequent-entry products – biosimilars – can become available. Biosimilars are not exact copies of their reference products but highly similar with regard to efficacy and safety and available at a discount. In Switzerland, relatively low biosimilar prescription rates have prompted interest in a health technology assessment (HTA) of the infliximab reference product relative to biosimilars for treating rheumatoid arthritis (RA). This scoping report determines the feasibility of such an HTA. We conducted a systematic literature search for evidence on efficacy, effectiveness, safety, and health economic outcomes of the infliximab reference product relative to biosimilars in RA. We also conducted a targeted search for evidence on biosimilar related ethical, legal, social, and organisational aspects. We identified 15 studies reporting on randomized controlled trials (RCTs), 14 real-world evidence (RWE) studies, and 11 health economic studies. RCTs reported a range of clinical efficacy, safety, pharmacokinetic/pharmacodynamic, immunogenicity, and patient-reported outcomes. RWE studies primarily reported on effectiveness, safety, and treatment discontinuation. Health economic studies were costing studies or budget impact analyses. A substantial body of literature was identified on biosimilar regulation in different settings. For legal and ethical aspects, we developed sets of questions that we considered important for discussing reference products and biosimilars, particularly with regard to non-medical switching. The evidence base suggested that an HTA comparing the infliximab reference product with its biosimilars for treatment of RA in infliximab-naïve and switched patients would be feasible. This HTA would have to include a systematic review (and possibly a meta-analysis) of efficacy, effectiveness, and safety as well as a budget impact analysis (but not necessarily a full economic evaluation).