英夫利昔单抗是一种针对肿瘤坏死因子α的嵌合单克隆抗体，GP1111（Zessly®，Sandoz）是欧洲最近批准的英夫利昔单抗生物仿制药。我们回顾了 GP1111 的审批流程和关键证据，主要关注类风湿性关节炎 (RA) 和炎症性肠病 (IBD) 的适应症。这篇叙述性综述讨论了 GP1111 的临床前、临床和真实世界数据。尽管接受甲氨蝶呤治疗，但对中度至重度活动性 RA 患者进行的 III 期 REFLECTIONS 试验证实了 GP1111 与参考英夫利昔单抗在疗效和安全性方面的相似性。在 REFLECTIONS 中从参考英夫利昔单抗转为 GP1111 对疗效或安全性没有影响。自2018年3月GP1111在欧洲获批以来，真实世界数据也证实了从另一种英夫利昔单抗生物类似药转为GP1111治疗RA和IBD患者的有效性和安全性。此外，对 RA 患者各种序贯靶向治疗的预算影响分析发现，在传统合成缓解病情抗风湿药物失败后尽早使用 GP1111 具有成本效益。因此，GP1111 批准后 5 年治疗 RA 和 IBD 的经验，以及关键的临床和现实世界证据，支持在所有英夫利昔单抗批准的适应症中继续使用 GP1111 的安全性和有效性。

Infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha, and GP1111 (Zessly®, Sandoz) is the most recently approved infliximab biosimilar in Europe. We reviewed the approval process and key evidence for GP1111, focusing primarily on the indications of rheumatoid arthritis (RA) and inflammatory bowel disease (IBD).This narrative review discusses pre-clinical, clinical, and real-world data for GP1111.Results from the Phase III REFLECTIONS trial in patients with moderate-to-severe active RA despite methotrexate therapy confirmed the similarity in efficacy and safety between GP1111 and reference infliximab. Switching from reference infliximab to GP1111 in REFLECTIONS had no impact on efficacy or safety. Since the European approval of GP1111 in March 2018, real-world data have also confirmed the efficacy and safety of switching from another infliximab biosimilar to GP1111 in patients with RA and IBD. In addition, budget impact analysis of various sequential targeted treatments in patients with RA found that GP1111 was cost-effective when used early after failure of conventional synthetic disease-modifying antirheumatic drugs. Therefore, 5 years' post-approval experience with GP1111 in RA and IBD, and key clinical and real-world evidence, support the safety and efficacy of continued use of GP1111 in all infliximab-approved indications.