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J Crohns Colitis. 2017 Jun 1;11(6):690-696. doi: 10.1093/ecco-jcc/jjw216.

Biosimilar Infliximab in Inflammatory Bowel Disease: Outcomes of a Managed Switching Programme.

Author information

Department of Gastroenterology, Southampton General HospitalSouthampton, UK.
Pharmaceutical Commissioning, West Hampshire CCG, Eastleigh, UK.
University of Southampton, Southampton General Hospital, Southampton, UK.
Department of Finance, Southampton General Hospital, Southampton, UK.
Department of Pharmacy, Southampton General Hospital, Southampton, UK.
Department of Allergy and Immunology, Southampton General Hospital, Southampton, UK.


Background and Aims:

Biosimilar infliximab CT-P13 offers the potential for large drug acquisition cost savings. However, there are limited published data regarding its efficacy, safety, and immunogenicity in inflammatory bowel disease [IBD], particularly in switching IBD patients from originator to biosimilar infliximab. We present the outcomes of a service evaluation of switching IBD patients established on originator infliximab to biosimilar, using a managed switching programme funded via a gain share agreement in a UK teaching hospital.


Evaluation outcomes included drug persistence, changes in drug acquisition costs, patient-reported side effects, adverse events, patient outcomes assessed using the IBD-control Patient-Reported Outcome Measures [PROM] questionnaire, serum drug and antibody levels, and routinely collected biochemical markers.


A total of 143 patients with IBD [118 Crohn's disease, 23 ulcerative colitis, 2 IBD unclassified] were switched from originator infliximab to CT-P13. Patients reported a similar incidence of side effects before and after switch. No clinically significant differences were observed in mean C-reactive protein [CRP], albumin, haemoglobin levels, or platelet and white cell counts after the switch to CT-P13, whereas mean IBD-control-8 score improved from 10.4 to 11.2 [p = 0.041]. There was no significant difference in drug persistence between biosimilar and originator infliximab [p = 0.94] and no increase in immunogenicity was found. Drug acquisition costs decreased by £40,000-60,000 per month.


A managed switching programme from originator infliximab to biosimilar CT-P13 in IBD, using a gain-share agreement, delivers significant cost savings and investment in clinical services while maintaining similar patient-reported outcomes, biochemical response, drug persistence, and adverse event profile.


Inflammatory bowel disease; Infliximab; biosimilar switching; biosimilars; gain share

[Indexed for MEDLINE]

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