Will US Follow UK on Managed Biosimilar Switching of IBD Patients on Infliximab?

Jackie Syrop
February 22, 2017
A study of a managed switching program among patients with inflammatory bowel disease (IBD), who were treated with infliximab (Remicade) and then switched to its biosimilar CT-P13 infliximab (Inflectra/Remsima), found that switching delivered significant cost savings and resulted in no significant differences between the 2 medications in terms of drug persistence, side effects, adverse reactions, disease activity, or biochemical response. The study has been published in the Journal of Crohn’s and Colitis.1
The study followed 143 patients with IBD (118, Crohn’s disease; 23, ulcerative colitis; and 2, unclassified IBD), all of whom had been on reference infliximab and agreed to participate in the switching program. 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 questionnaire (IBD-Control-8), serum drug and antibody levels, and routinely collected biochemical markers. Patients reported a similar incidence of side effects before and after the switch. No clinically significant differences were observed in mean C-reaction protein, albumin, hemoglobin levels, or platelet and white cell counts after the switch to CT-P13. The mean IBD-control-8 score improved from 10.4 to 11.2 (P = .041). There was no significant difference in drug persistence between biosimilar and reference infliximab (P = .94) and no increase in immunogenic response to the biosimilar.
Investment in the new program, including salary for an IBD specialist nurse and other support staff, was about 12% of expected cost savings. The analysis showed substantial cost savings to the health economy, part of which has been reinvested in not only delivering the program but also improving the service and quality of care for the whole IBD patient population in Southampton—not just for biologics-treated patients. The authors write that drug acquisition costs fell by £40,000 to £60,000 pounds (approximately $50,000 to $75,000) after the managed switching program began.
In the European Union (EU), interchangeability of approved biosimilars with reference biologics does not require prescriber approval. However, in the United States, pharmacy-level switching is not allowed unless a biosimilar has the FDA’s interchangeable designation; none of the US-approved biosimilars are yet deemed interchangeable. Switching studies such as this are likely to play an important role in demonstrating the interchangeability of US biosimilars and reference drugs, according to the recently issued FDA draft guidance for pharma.


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