Infliximab biosimilar safety & efficacy

Jan 29, 2019 - E-Mentoring in IBD | Volume 12 • 2019

Issue 02

Clinical Question

Is there a difference in safety and efficacy between reference infliximab and biosimilar CT-P13?

Editor’s Bottom Line

Reference infliximab and biosimilar CT-P13 appeared to yield similar outcomes in a large, real-world cohort. These data support use of biosimilars in treatment-naïve patients.


Meyer A, Rudant K, Drouin J, et al. Effectiveness and Safety of Reference Infliximab and Biosimilar in Crohn Disease: A French Equivalence Study. Ann Intern Med. 2019;170(2):99–107. DOI: 10.7326/M18-1512


The infliximab biosimilar CT-P13 (Inflectra; Celltrion) was approved in Canada in 2016 for the treatment of Crohn’s disease (CD), fistulising CD and ulcerative colitis. That approval was based on studies examining the equivalence of CT-P13 and reference infliximab (Remicade; Janssen Biotech) for the treatment of rheumatoid arthritis and spondyloarthritis.

In this study, French researchers examined data from 2,551 CD patients who received reference infliximab and 2,499 who received CT-P13. Patients were registered in a large French administrative database that includes nearly all of the French population. The median follow-up was 366 days for reference infliximab recipients and 286 days for biosimilar recipients. Patients received at least one infliximab infusion between March 2015 and November 2016.

The researchers’ primary end-point was a composite of death, CD-related surgery, all-cause hospitalization, and reimbursement for adalimumab, vedolizumab and ustekinumab, which they used as a proxy measure of infliximab treatment failure.

Results showed no differences in the composite end-point between groups, with 43.1% of reference infliximab recipients and 41.6% of CT-P13 recipients meeting the end-point at one year. A multivariable analysis confirmed rates of this outcome were statistically similar in the two cohorts (Hazard Ratio for composite end-point for CT-P13 vs. reference infliximab, 0.92; 95% Confidence Interval, 0.85 to 0.99; P not significant). Additionally, rates of serious infections, tuberculosis and solid or hematologic cancer did not differ between groups.

The researchers noted that a weakness of the study was that the French database did not contain clinical data such as disease activity.


Study Design: Observational cohort
Funding: Caisse Nationale de l’Assurance Maladie
Allocation: Not applicable
Setting: Database
Level of Evidence: 2b (Oxford Levels of Evidence)

The summary and conclusion in this issue of E-mentoring in IBD pertains to the manuscript(s) being reviewed, and should be considered in the context of what is already known surrounding the topic and incorporated into practice as deemed appropriate by the individual learner.