OBJECTIVES: Infliximab biosimilars (IFX-B) have been introduced in recent years as therapeutic alternatives to originator infliximab (IFX-O). These have been approved in Europe, the United States, and Canada for the treatment of chronic conditions such as rheumatoid arthritis and Crohn’s disease. Real-world evidence (RWE) may provide valuable information about the long-term effectiveness and safety of IFX-B compared to IFX-O outside of the clinical trial setting, and scoping reviews may guide research question development for future work in this area. This study aimed to review the use of RWE to evaluate IFX-B for the treatment of inflammatory, rheumatic, and autoimmune diseases.

METHODS: A search strategy was implemented in MEDLINE and Embase in September 2020 using indexed terms and keywords related to biosimilars, originators, and observational study designs. Abstracts and full-text articles describing the evaluation of IFX-B using RWE were included. Outcomes of interest were number (%) of studies comparing IFX-B and IFX-O, and of these, number (%) describing clinical effectiveness, safety/tolerability (adverse events/discontinuations), biomarkers, and healthcare resource utilization (HRU). Number (%) of studies evaluating switch from IFX-B to IFX-O were also determined.

RESULTS: Of 1,739 abstracts identified, 164 (9.4%) assessed IFX-B using RWE and were included. Among included studies, 67 (40.9%) compared IFX-B and IFX-O; the most frequently reported outcomes in these studies were safety/tolerability (47, 70.1%), clinical effectiveness (43, 64.2%), and biomarker levels (31, 46.3%). HRU was infrequently reported among studies comparing IFX-B and IFX-O (10, 14.9%). 103 (62.8%) included studies reported at least one of these outcomes following switch from IFX-O to IFX-B.

CONCLUSIONS: This scoping review described the availability of research on IFX-B using RWE. Despite the preliminary nature of this review, findings highlighted a paucity of RWE on HRU associated with IFX-B. Future work to characterize HRU/costs associated with IFX-B compared to IFX-O may be valuable.