Outcomes of a mandatory non-medical switch of infliximab to a biosimilar for inflammatory bowel disease in British Columbia, Canada.

Background: Despite infliximab biosimilars becoming widely used in inflammatory bowel disease (IBD) patients, real-world non-medical switching is sparse. A biosimilar non-medical switch was launched in British Columbia in 2019, the first Canadian province to do so, from Remicade to an approved biosimilar (CT-P13 or SB2).
Aims: This study aims to obtain real-world evidence evaluating the clinical outcomes of non-medical switching from Remicade to the infliximab biosimilars.
Methods: This is a retrospective observational study of stable IBD patients from the IBD Centre of BC who underwent the non-medical infliximab switch. The primary outcome is treatment continuation at 12 ± 2 months post-switch. Secondary outcomes include frequency of loss of response, adverse events, and immunogenicity within the first 12 months post-switch. A control group of patients maintained on the originator served as a comparison.
Results: Patients in the biosimilar switch group ( n = 264) and originator group ( n = 99), show similar demographics and disease characteristics. There was no difference in infliximab continuation between the biosimilar group (94.9%) and the originator group (90.1%) ( P = 0.18). Reasons for discontinuation of infliximab included loss of response (4.04% vs 4.91%), immunogenicity (1.01% vs 0.75%), or adverse effect (1.01% vs 2.3%) in the infliximab originator vs biosimilar switch group, respectively. Similarly, no differences in safety or efficacy were observed between patients switched to CT-P13 or SB2.
Conclusions: Non-medical biosimilar switch of infliximab demonstrates similar clinical outcomes compared to originator molecule continuation for therapy of IBD. These data support the safety and efficacy of non-medical infliximab switching in IBD patients.
Competing Interests: T.T.H., J.R., and C.G. have no relevant conflicts of interest to disclose. Y.L. has served on advisory boards and received speaker fees from Janssen, Abbvie, Organon, Pfizer, Takeda, BMS, Amgen, and Eli Lilly. B.B. has served on advisory boards and received speaker fees from Ferring, Janssen, Abbvie, Takeda, Pfizer, Novartis, BMS, Merck, Sandoz, Organon, and Lifelabs. B.B. has served on the advisory boards of Alimentiv, Gilead, Iterative Scopes, AMT, Celgene, Merck, Amgen, Pendopharm, Genentech, BMS, Allergan, Protagonist, Fresenius Kabi, Mylan, Viatris, Bausch Health, Celltrion Healthcare, BioJamp Pharma, and Eupraxia. B.B. has received research support, though not directly for this project from Janssen, Abbvie, GSK, BMS, Amgen, Genentech, and Merck. G.R. has received honoraria from Abbvie, Frensius-Kabi, Janssen, Pfizer, Takeda, Merck, Amgen, Viatris, Organon and Ferring as a speaker, adviser and consultant. Research Grant support from Abbvie, Fresnius-Kabi, Ferring and Crohn’s and Colitis Canada. Together, no funding was directly provided for this work.
(© The Author(s) 2024. Published by Oxford University Press on behalf of the Canadian Association of Gastroenterology.)