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Background and Aim  CT‐P13, an infliximab (IFX) biosimilar, was approved for treatment of inflammatory bowel disease. However, no comparison with the originator IFX in this indication has been conducted in Japan where endemic levels of tuberculosis and hepatitis virus infection are not low. We evaluated the safety and efficacy in real‐world data of CT‐P13 and compared with originator IFX data in Japan.    Methods  In a prospective post‐marketing surveillance (PMS) study, patients who received CT‐P13 in a 28‐month period from January 2015 were followed up for 2 years. By conducting Japanese administrative database search (DBS) for the same period of PMS, data of the originator IFX including treatment persistence, tuberculosis incidence, and liver injury were analyzed retrospectively and compared with the corresponding PMS data of CT‐P13.    Results  CT‐P13 persistence in PMS ( n  = 640) and IFX persistence in DBS ( n  = 4113) were almost similar between patients who switched from the originator and patients who continued on the originator, and also between the biologics‐naïve patient groups. There were no differences in the incidences of tuberculosis and hepatic injury (Tuberculosis: 2 patients [0.31%] with CT‐P13, 10 patients [0.24%] with the originator,  P  = 0.75; Hepatic injury: 18.5% with CT‐P13, 15.4% with the originator,  P  = 0.22). Most of the patients with hepatic injury continued treatment in PMS and DBS at similar rates (80.8%  vs  83.6%,  P  = 0.65).    Conclusion  The results of long‐term PMS of CT‐P13 compared with external reference data from an administrative database suggested that the biosimilar and its originator were comparably useful in real‐world clinical practice.

Post‐marketing analysis for biosimilar CT‐P13 in inflammatory bowel disease compared with external data of originator infliximab in Japan