A study newly published in Archives of Disease in Childhood sought to develop much-needed data specific to the treatment of pediatric inflammatory bowel disease with biosimilar infliximab, with a focus on safety and effectiveness.
Biosimilar infliximab CT-P13 became available for use in the United Kingdom in 2015, but pediatric experience with the therapy has been limited. Use of reference infliximab (Remicade) in patients with pediatric inflammatory bowel disease (PIBD) was notably limited by the lack of a pediatric license for the therapy, as well as by the high cost of therapy. Furthermore, studies demonstrating biosimilarity of CT-P13 and its reference were conducted in rheumatologic indications that did not use standard dosing strategies for the treatment of IBD or PIBD.
A study newly published in Archives of Disease in Childhood sought to develop much-needed data specific to the treatment of PIBD with biosimilar infliximab, with a focus on safety and effectiveness. The study found that CT-P13 (which is marketed as both Remsima and Inflectra) was both as effective as the reference infliximab and responsible for significant cost savings in the treatment of children with PIBD.
In the study, all patients in 2 regional health systems in Scotland who had PIBD and who were initiating treatment with infliximab were given CT-P13. Forty patients initiated treatment with CT-P13 between August 2015 and June 2016. Of this group, 29 patients had Crohn’s disease, and 11 had either ulcerative colitis or unclassified IBD. The patients had a median age of 13.7 years (range, 13 to 16) at the time they began treatment.
Data were collected at initiation, and patient response was reviewed following 3 induction doses (approximately 12 weeks after treatment initiation). Prospective clinical data were collected from laboratory reports, electronic patient records, and case notes. The weighted Pediatric Crohn’s Disease Activity Index (wPCDAI) and Pediatric Ulcerative Colitis Activity Index (PUCAI) were used to document disease activity at initiation and follow up. The cost for originator infliximab versus the cost of the biosimilar were obtained from a national framework agreement on drug procurement for Scotland.
The researchers found the following:
The average cost per vial of the biosimilar during the treatment period was approximately 38% lower than that of the reference infliximab. The authors estimate that the total cost savings produced by using the biosimilar during the study period was £47,800 (approximately $62,785).
The authors conclude that using biosimilar infliximab in patients with PIBD is as safe and effective as using the originator infliximab in the short term, and that the biosimilar’s use was associated with a significant cost savings to the health system.
The authors say that “These baseline data have now enabled us to confidently switch patients from originator to biosimilar, adopting the same prospective methodology to monitor effectiveness, safety and cost,” and that they hope that their study will encourage the wider introduction of biosimilar anti—tumor necrosis factor agents in pediatric practice.
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?
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
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.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
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.