ABSTRACT

Introduction

Biologic drugs have significantly improved the treatment of ulcerative colitis (UC) and Crohn’s disease (CD). However, the availability of these drugs is limited by their high cost. Infliximab was the first biologic to be approved for inflammatory bowel diseases (IBD). After its patent expired other manufactures developed biosimilar versions, among which CT-P13, and licensed them thorough an expedite process.

Areas covered

The aim of this review is to summarize the available evidence on CT-P13 use in IBD, with particular interest in the phase II trials of a subcutaneous version of CT-P13.

Expert opinion

Biosimilars, such as CT-P13, are an important resource for health-care systems. Although CT-P13 approval in IBD was based on extrapolation, subsequent studies confirmed its clinical equivalence to originator infliximab. A new subcutaneous formulation of CT-P13 showed promising results in phase I and II trials in both CD and UC. Clinical efficacy and safety were comparable and interestingly serum drug doses appeared to be more stable than conventional intravenous CT-P13. If these preliminary results will be confirmed, the first sub-cutaneous version of infliximab could soon be available for IBD.

中文翻译：

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炎症性肠病中英夫利昔单抗生物仿制药的演变：从静脉注射到皮下 CT-P13。

摘要

介绍

生物药物显着改善了溃疡性结肠炎 (UC) 和克罗恩病 (CD) 的治疗。然而，这些药物的可用性受到其高昂成本的限制。英夫利昔单抗是第一个被批准用于炎症性肠病 (IBD) 的生物制剂。在其专利到期后，其他制造商开发了生物仿制药版本，其中包括 CT-P13，并通过加速程序获得许可。

覆盖区域

本综述的目的是总结关于 CT-P13 在 IBD 中使用的现有证据，特别关注 CT-P13 皮下版本的 II 期试验。

专家意见

CT-P13 等生物仿制药是医疗保健系统的重要资源。尽管 CT-P13 在 IBD 中的批准是基于外推法，但随后的研究证实了其与原研药英夫利昔单抗的临床等效性。CT-P13 的新皮下制剂在 CD 和 UC 的 I 和 II 期试验中显示出有希望的结果。临床疗效和安全性相当，有趣的是，血清药物剂量似乎比常规静脉注射 CT-P13 更稳定。如果这些初步结果得到证实，英夫利昔单抗的第一个皮下版本很快就会用于 IBD。