: 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). : 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. : 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.
Download full-text PDF |
Source |
---|---|
http://dx.doi.org/10.1080/14712598.2019.1653848 | DOI Listing |
J Clin Med
November 2024
Division of Rheumatology, School of Medicine, Dokuz Eylul University, 35220 Izmir, Turkey.
CT-P13 is a biosimilar version of infliximab, a monoclonal antibody. In individuals with ankylosing spondylitis (AS), CT-P13 has been shown to be effective and to have a well-tolerated safety profile. The aim of this study was to evaluate the long-term drug persistence, safety, and efficacy of infliximab biosimilar CT-P13 in patients with AS undergoing first-line (1st-line) and later (≥2nd-line) treatment in clinical practice.
View Article and Find Full Text PDFGastroenterology
November 2024
Department of General Surgery, Peking Union Medical College Hospital, Beijing, China.
BMC Gastroenterol
November 2024
Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000, China.
Background: Since 2015, an infliximab biosimilar, CT-P13, has been approved for commercial use in many countries, easing the economic burden borne by society and patients. Many clinical trials investigating CT-P13 for the treatment of IBD have been conducted and reported that it may be a substitute for infliximab. However, the differences between the efficacy of CT-P13 and infliximab-originator require further elucidation.
View Article and Find Full Text PDFPLoS One
November 2024
Health Technology Assessment Unit, King Fahd Armed Forces Hospital, Jeddah, Saudi Arabia.
Background: The Saudi Food and Drug Authority (SFDA) has approved the subcutaneous (SC) administration of infliximab, presenting a more convenient alternative with reduced outpatient visits and diminished expenses compared to the intravenous (IV) administration. However, the financial implications of this formulation have not been examined from the perspective of Saudi payers.
Methods And Materials: A prevalence-based budget impact model was developed to evaluate the financial effects of introducing "environment without" versus "with infliximab SC.
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!