BACKGROUND & AIMS:
:A biosimilar is a copy of an approved biological medicine whose patent protections have expired. Biosimilars of antibodies to tumour necrosis factor α (TNFα) are becoming important in the treatment of inflammatory bowel diseases (IBD). The first one introduced commercially is an infliximab biosimilar. The aim of this study was to provide an overview of anti-TNFα biosimilars. The literature on biosimilars of monoclonal anti-TNFα antibodies was reviewed, including their manufacture and approval pathways, concerns about efficacy, safety, immunogenicity, extrapolation, switching and labelling. Previous experience with biosimilars of epoetin and other growth factors was also reviewed. The infliximab biosimilar CT-P13 was the first biosimilar monoclonal antibody registered for the treatment of IBD. The major advantage of biosimilars is the reduced cost of therapy. Concerns have arisen, however, about the efficacy and safety of CT-P13 in IBD, the extrapolation of results from rheumatologic trials to IBD and the free interchangeability of CT-P13 with infliximab. Experience with simple peptide biosimilars, such as epoetins and growth factors, has generally been positive, with these biosimilars having similar efficacy and safety as the original products, although immunogenicity remains a major concern. Upcoming postregistration studies will address concerns on biosimilars in IBD, including their efficacy, safety, immunogenicity, switching and interchangeability. Biosimilars active against the same epitopes, but with improved pharmacokinetic properties that enhance their efficacy and/or safety, may be the next stage in the development of biosimilars. Anti-TNFα biosimilars represent promising new treatment options for patients with IBD. However, data on their efficacy and safety in IBD are needed.
背景与目标:
:生物仿制药是专利保护已过期的已批准生物药品的副本。肿瘤坏死因子α(TNFα)抗体的生物仿制药在治疗炎症性肠病(IBD)中变得越来越重要。商业上第一个引入的是英夫利昔单抗生物仿制药。这项研究的目的是提供抗TNFα生物仿制药的概述。综述了有关单克隆抗TNFα抗体生物仿制药的文献,包括其制备和批准途径,对功效,安全性,免疫原性,外推,转换和标记的关注。还回顾了以往使用依泊汀和其他生长因子的生物仿制药的经验。英夫利昔单抗生物仿制药CT-P13是第一个注册用于治疗IBD的生物仿制药单克隆抗体。生物仿制药的主要优点是降低了治疗成本。然而,有关CT-P13在IBD中的功效和安全性,风湿病试验结果向IBD的推断以及CT-P13与英夫利昔单抗的自由互换性等问题引起了人们的关注。简单的肽类生物类似物(如表蛋白和生长因子)的经验通常是积极的,尽管免疫原性仍然是主要关注的问题,但这些生物类似物具有与原始产品相似的功效和安全性。即将进行的注册后研究将解决对IBD中生物仿制药的关注,包括其功效,安全性,免疫原性,转换和互换性。生物仿制药对相同的表位具有活性,但具有改善的药代动力学特性,可增强其功效和/或安全性,可能是生物仿制药开发的下一阶段。抗TNFα生物仿制药代表了IBD患者的有希望的新治疗选择。但是,需要有关其在IBD中的疗效和安全性的数据。