Abstract
ABSTRACT Introduction: CT-P13 was developed as an infliximab biosimilar in 2013. The primary structure of CT-P13 is identical to that of original infliximab and it has highly similar higher order structure, physiochemical characteristics, and biological properties. To date, data from real-life cohorts and randomized controlled trials show comparable clinical efficacy, safety and immunogenicity of biosimilar CT-P13, and the original reference medicinal Product (RMP). Areas covered: This article reviews the comparability of CT-P13 and the RMP and focuses on the emerging clinical trial and observational cohorts data on efficacy and safety of CT-P13 in inflammatory bowel disease (IBD) patients. The development of a subcutaneous formulation of Infliximab CT-P13 is also addressed. Expert opinion: There is a plethora of evidence to show CT-P13 is non-inferior to infliximab RMP in IBD and that a switch from RMP to this biosimilar is feasible and safe. However, interchangeability and multiple switches can still not be endorsed for introduction into clinical practice.
Published Version
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