Anti-TNF therapy is effective in IBD but the high costs of some biologic agents necessitate the development of biosimilar drugs. CT-P13 is a biosimilar of the anti-TNF agent infliximab and has been approved for patients with IBD on the basis of extrapolation in other indications, but a direct comparison of infliximab with a biosimilar for patients with IBD was lacking. Now, in a phase III randomized controlled trial, 220 patients with Crohn’s disease and naive to biologic agents were allocated to groups receiving CT-P13 or infliximab for 1 year, with a switch in therapy at week 30. After 6 weeks, the proportion of patients with a ≥70-point decrease in Crohn’s Disease Activity Index scores were similar in groups receiving CT-P13 or infliximab, establishing non-inferiority for CT-P13. Over the full study period, treatment-emergent adverse events were also similar between the groups.
Ye, B. D. et al. Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn’s disease: an international, randomised, double-blind, phase 3 non-inferiority study. Lancet 393, 1699–1707 (2019)
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Dickson, I. CT-P13 biosimilar is non-inferior to infliximab. Nat Rev Gastroenterol Hepatol 16, 326 (2019). https://doi.org/10.1038/s41575-019-0155-5