Abstract:
The introduction of anti-tumor necrosis factor α (TNFα) biologics significantly innovated inflammatory bowel disease (IBD) treatment and increased medical costs. The recent expiration of patents of some anti-TNFα biologics (such as infliximab and adalimumab) facilitated the development of biosimilars. Comparable pharmacokinetic, efficacy, safety, and immunogenicity profiles between anti-TNFα originators and biosimilars were demonstrated in different studies. Anti-TNFα biosimilars hold promise for reducing the high cost of biologics and increasing patient access to biologics. In this review, we outline the current data on the use of anti-TNFα originators and biosimilars in patients with IBD, with a focus on the efficacy, safety, and immunogenicity profiles of infliximab and adalimumab biosimilars. The potential benefits, challenges, and future directions of anti-TNFα biosimilars are also discussed in the review.
摘要:
抗肿瘤坏死因子α(TNFα)生物制剂的引入显着创新了炎症性肠病(IBD)的治疗方法并增加了医疗成本。一些抗TNFα生物制剂(例如英夫利昔单抗和阿达木单抗)的专利最近到期,促进了生物仿制药的开发。相当的药代动力学,功效,安全,在不同的研究中证明了抗TNFα起源和生物仿制药之间的免疫原性谱。抗TNFα生物仿制药有望降低生物制剂的高成本并增加患者获得生物制剂的机会。在这次审查中,我们概述了IBD患者使用抗TNFα和生物类似药的最新数据,注重功效,安全,英夫利昔单抗和阿达木单抗生物仿制药的免疫原性谱。潜在的好处,挑战,本文还讨论了抗TNFα生物仿制药的未来发展方向。