Zeng Zhen, Lin Hao, Jiang Mingshan, Yuan Jing, Li Xi, Jia Yongbin, Yang Li, Zhang Hu
Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu, China.
Centre for Inflammatory Bowel Disease, West China Hospital, Sichuan University, Chengdu, China.
Front Pharmacol. 2024 Jul 24;15:1424606. doi: 10.3389/fphar.2024.1424606. eCollection 2024.
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.
抗肿瘤坏死因子α（TNFα）生物制剂的引入显著革新了炎症性肠病（IBD）的治疗方法，但也增加了医疗成本。近期一些抗TNFα生物制剂（如英夫利昔单抗和阿达木单抗）的专利到期，推动了生物类似药的发展。不同研究表明，抗TNFα原研药和生物类似药在药代动力学、疗效、安全性和免疫原性方面具有可比性。抗TNFα生物类似药有望降低生物制剂的高昂成本，并增加患者获得生物制剂的机会。在本综述中，我们概述了目前关于抗TNFα原研药和生物类似药在IBD患者中应用的数据，重点关注英夫利昔单抗和阿达木单抗生物类似药的疗效、安全性和免疫原性。本综述还讨论了抗TNFα生物类似药的潜在益处、挑战和未来发展方向。
