Kay Jonathan, Cross Raymond K, Feldman Steven R, Park Younjin, Hanauer Stephen B
Division of Rheumatology, Department of Medicine, UMass Chan Medical School, Worcester, MA, 01605, USA.
Division of Gastroenterology and Hepatology, Department of Medicine, University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.
Adv Ther. 2024 Feb;41(2):509-533. doi: 10.1007/s12325-023-02737-1. Epub 2023 Dec 19.
SB5 is an approved biosimilar of adalimumab, a recombinant monoclonal anti-tumor necrosis factor (TNF) antibody. The approval of SB5 was based on the comparison with reference adalimumab in analytical studies, pharmacokinetic (PK) and immunogenicity assessments, and randomized controlled trials. Efficacy data was primarily obtained in patients with rheumatoid arthritis, and extended to include additional indications such as psoriasis, Crohn's disease, or ulcerative colitis by extrapolation. Following its approval, additional post-marketing data have been collected comparing SB5 with reference adalimumab. This review summarizes the clinical data on SB5 from randomized controlled trials and provides a comprehensive overview of the available post-approval data. In "real-world" settings, SB5 was as effective as its reference product across different indications and countries, treatment persistence was well maintained throughout studies, and no new safety concerns were identified. In both controlled and "real-world" settings, switching from reference adalimumab to SB5 was not associated with altered efficacy or clinical complications. In post-approval studies, the quality of SB5 was consistent over time, independent of the batch and process changes, and the SB5 autoinjector was preferred over other autoinjectors by both healthcare professionals and patients. Taken together, these data support the use of SB5 whenever reference adalimumab is appropriate and demonstrate that switching from reference adalimumab to SB5 is feasible.
SB5是阿达木单抗的一种获批生物类似药，阿达木单抗是一种重组单克隆抗肿瘤坏死因子（TNF）抗体。SB5的获批基于在分析研究、药代动力学（PK）和免疫原性评估以及随机对照试验中与参比阿达木单抗的比较。疗效数据主要来自类风湿性关节炎患者，并通过外推法扩展至包括银屑病、克罗恩病或溃疡性结肠炎等其他适应症。获批后，已收集了将SB5与参比阿达木单抗进行比较的更多上市后数据。本综述总结了随机对照试验中关于SB5的临床数据，并全面概述了获批后的可用数据。在“真实世界”环境中，SB5在不同适应症和国家与参比产品一样有效，在整个研究过程中治疗持续性得到良好维持，且未发现新的安全问题。在对照和“真实世界”环境中，从参比阿达木单抗转换为SB5均与疗效改变或临床并发症无关。在获批后研究中，SB5的质量随时间保持一致，与批次和工艺变化无关，并且医疗保健专业人员和患者都更青睐SB5自动注射器而非其他自动注射器。综上所述，这些数据支持在参比阿达木单抗适用时使用SB5，并表明从参比阿达木单抗转换为SB5是可行的。
