Department of Gastroenterology, Sheba medical center, Sackler School of Medicine Tel-Aviv University , Israel.
Expert Opin Biol Ther. 2019 Oct;19(10):971-978. doi: 10.1080/14712598.2019.1653848. Epub 2019 Aug 23.
: 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.
: CT-P13 于 2013 年被开发为英夫利昔单抗的生物类似药。CT-P13 的一级结构与原研英夫利昔单抗相同，其高级结构、理化特性和生物学特性也高度相似。迄今为止，来自真实队列和随机对照试验的数据表明，生物类似药 CT-P13 与原研参考药物（RMP）具有相当的临床疗效、安全性和免疫原性。 : 本文综述了 CT-P13 与 RMP 的相似性，并重点介绍了新兴的临床试验和观察队列数据，评估 CT-P13 在炎症性肠病（IBD）患者中的疗效和安全性。同时还讨论了英夫利昔单抗 CT-P13 的皮下制剂的开发情况。 : 大量证据表明 CT-P13 在 IBD 中的疗效不劣于英夫利昔单抗 RMP，从 RMP 转换为这种生物类似药是可行且安全的。然而，互换性和多次转换仍不能被认可引入临床实践。
