The authors concluded that in their analysis of real-world data, the effectiveness of the biosimilar was equivalent to that of the reference product in patients with Crohn disease (CD) who were naïve to therapy with infliximab, and no difference was observed in terms of safety between the 2 therapies.
Celltrion’s CT-P13, an infliximab biosimilar approved in the United States as Inflectra and in the European Union as Remsima, is widely used in the treatment of inflammatory diseases, and was approved on the basis of studies conducted in rheumatoid arthritis and ankylosing spondylitis.
An extrapolated indication was granted for the treatment of Crohn disease (CD), and since approval, numerous real-world data have supported the use of CT-P13 in patients with CD. A new study, published this week in Annals of Internal Medicine, further underscores the safety and effectiveness of CT-P13 in this disease state.
The comparative equivalence cohort study compared CT-P13 with the reference infliximab, Remicade, in patients with CD who were naïve to infliximab therapy. In total, 5050 patients aged 15 years or older were enrolled in the study, and 2551 were given the reference infliximab, while 2499 were given the biosimilar. None of the patients had other diseases with an indication for treatment with infliximab.
The study’s primary outcome was a composite end point of death, CD-related surgery, all-cause hospitalization, and reimbursement for another biologic treatment. The predefined equivalence margin (0.80-1.25) was defined as a 95% CI of the hazard ratio (HR) of CT-P13 versus the reference product in a multivariable marginal Cox model.
In total, 1147 patients in the reference group met the composite end point, with 838 hospitalizations. In the biosimilar group, 952 patients, with 719 hospitalizations, met the end point. In a multivariable analysis, CT-P13 was equivalent to the reference infliximab, with an HR of 1.10 (95% CI, 0.26-3.34).
There were no differences in safety outcomes between the 2 groups with respect to serious infection (HR, 0.82; 95% CI, 0.61-1.11), tuberculosis (HR, 1.10; 95% CI, 0.36-3.34), or malignancy (HR, 0.66; 95% CI, 0.33-1.32).
The authors concluded that in their analysis of the real-world data, the effectiveness of the biosimilar was equivalent to that of the reference product in patients with CD who were naïve to therapy with infliximab, and no difference was observed in terms of safety between the 2 therapies.
Reference
Meyer A, Rudant J, Drouin J, Weill A, Carbonnel F, Coste J. Effectiveness and safety of reference infliximab and biosimilar in Crohn disease: a French equivalence study [published online December 11, 2018]. Ann Intern Med. doi: 10.7326/M18-1512.
The Growing Impact of Biosimilars in IBD Care
April 23rd 2025Biosimilars are proving to be a game-changing solution in the fight against inflammatory bowel disease (IBD), offering a cost-effective alternative to biologics with similar efficacy and safety, while innovative drug delivery systems promise to further enhance treatment outcomes and accessibility for millions worldwide.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Biosimilar and Biologic Use Increasing in Greek Patients With IBD
April 19th 2025A retrospective study from a single inflammatory bowel disease (IBD) center in Greece reported that from 2018 to 2022, the use of biologics increased by 28% yearly, and the proportion of patients using biosimilars grew from 33% to 67%.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Latest Biosimilar Deals Signal Growth Across Immunology, Oncology Markets
April 14th 2025During Q1 2025, pharmaceutical companies accelerated biosimilar expansion through strategic acquisitions and partnerships in hopes of boosting patient access to lower-cost treatments in immunology and oncology.
Early Success of Adalimumab Biosimilars Featured at AMCP 2025
April 5th 2025High adherence rates, comparable clinical effectiveness, and cost savings have marked the early adoption of adalimumab biosimilars in the US, particularly in formulary-driven transitions, as shown in 2 retrospective studies presented at the Academy of Managed Care Pharmacy annual meeting (AMCP 2025).