抗肿瘤坏死因子生物类似药的兴起:指南,真实世界的证据和接受的挑战

Nicola Humphry
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引用次数: 2

摘要

TNF-α的过量产生可导致免疫介导的炎症性疾病(IMID)的慢性炎症和器官损伤,如类风湿关节炎(RA)、轴性脊柱炎、牛皮癣和炎症性肠病(IBD)。抗肿瘤坏死因子治疗通常被认为是治疗慢性炎症的有效且耐受性良好的治疗选择。在过去的十年中,原始参考抗tnf药物的专利已经过期,允许开发与原始参考产品生物相似的抗tnf产品,称为“生物类似药”。审批过程的差异意味着,与参考产品相比,医疗保健服务部门通常可以以相当低的成本获得生物仿制药,这为改善患者获得抗tnf治疗益处提供了机会。然而,尽管生物仿制药在医疗保健服务中的使用越来越广泛,一些临床医生仍然不愿意开处方。生物仿制药实际使用的长期数据的逐渐积累,以及对这些产品的开发和批准过程的进一步了解,可能有助于增加临床医生增加生物仿制药使用的信心。本综述总结了抗肿瘤坏死因子生物类似药在临床实践中的现状,包括监管部门批准的要求、其与新型抗肿瘤坏死因子等效性的实际证据、其使用指南以及临床医生和患者对其接受程度的挑战。
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The Rise of Anti-TNF Biosimilars: Guidelines, Real-World Evidence, and Challenges to Acceptance
The over-production of TNF-α can lead to chronic inflammation and organ damage in immune-mediated inflammatory diseases (IMID), such as rheumatoid arthritis (RA), axial spondyloarthritis, psoriasis, and inflammatory bowel disease (IBD). Anti-TNF therapy is generally considered to be an effective, well-tolerated treatment option for the management of chronic inflammation in these conditions. Over the past decade, patents for the original reference anti-TNF agents have expired, permitting the development of anti-TNF products that are biologically similar, termed ‘biosimilar’, to the original reference product. Differences in the approval process mean that biosimilars are often available to healthcare services at a considerably lower cost compared with the reference products, providing an opportunity to improve patient access to the benefits of anti-TNF therapy. However, despite the spreading use of biosimilars across healthcare services, some clinicians remain reluctant to prescribe them. The gradual accumulation of long-term data on the real-world use of biosimilars, and an improved understanding of the development and approval process for these products, may help to increase clinicians’ confidence to increase usage of biosimilars. This mini review summarises the current status of anti-TNF biosimilars in clinical practice, including the requirements for regulatory approval, real-word evidence for their equivalence to novel anti-TNFs, guidelines for their use, and challenges to their acceptance by both clinicians and patients.
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