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在美国境外从阿达木单抗参比制剂转换为阿达木单抗生物类似药以及在不同阿达木单抗生物类似药之间的转换:给美国临床医生的见解

Switching from Adalimumab Reference Product to and Among Adalimumab Biosimilars Outside the USA: Insights for US Clinicians.

作者信息

Tesser John R P, Charabaty Aline, Hebert Adelaide A

机构信息

Arizona Arthritis and Rheumatology Research, Phoenix, AZ, USA.

Johns Hopkins University School of Medicine, Washington, DC, USA.

出版信息

BioDrugs. 2025 Apr 22. doi: 10.1007/s40259-025-00719-z.

Abstract

Ten adalimumab biosimilars have been introduced in the United States (USA) since 2023, while adalimumab biosimilars have been available for several years in other countries. These experiences of biosimilar uptake outside the USA can inform US-based healthcare professionals on switching in real-life practice settings. Considerations include how healthcare professionals might meaningfully address patient concerns about outcomes to improve patient satisfaction. A search of the MEDLINE database was used to identify publications on switching to and among adalimumab biosimilars in an ex-US setting, with no restriction on publication language and using a time frame of 1 January 2017 through 12 December 2023, coinciding with the European Union approval of the first adalimumab biosimilar, adalimumab-atto, in March 2017. This narrative review aims to provide insights into the efficacy and safety of transitioning to and among adalimumab biosimilars in adult patients from clinical studies but also, more importantly, using real-world evidence (RWE) from outside the USA. Overall, RWE suggested that efficacy and outcomes were consistent in patients who underwent switching from the reference product (RP) across various immune-mediated inflammatory diseases when compared to patients who did not switch from the RP. The ex-US RWE of RP and biosimilar adalimumab switches generally reflected the experiences observed in clinical trials; however, RWE findings elucidated several challenges to biosimilar uptake, including patient education, provider training, and supportive policies.

摘要

自2023年以来,美国已引入10种阿达木单抗生物类似药,而在其他国家,阿达木单抗生物类似药已上市数年。美国以外地区生物类似药的使用经验可为美国的医疗保健专业人员在实际临床环境中的换药提供参考。需要考虑的因素包括医疗保健专业人员如何切实解决患者对治疗结果的担忧,以提高患者满意度。通过检索MEDLINE数据库,以确定在美国以外地区关于换用阿达木单抗生物类似药及在不同阿达木单抗生物类似药之间转换的相关出版物,对出版语言无限制,时间范围为2017年1月1日至2023年12月31日,这与欧盟于2017年3月批准首个阿达木单抗生物类似药阿达木单抗 - 阿托(adalimumab-atto)的时间一致。本叙述性综述旨在深入了解成年患者换用阿达木单抗生物类似药及在不同阿达木单抗生物类似药之间转换的疗效和安全性,不仅基于临床研究,更重要的是利用来自美国以外地区的真实世界证据(RWE)。总体而言,真实世界证据表明,与未从参照产品(RP)换药的患者相比,在各种免疫介导的炎症性疾病中,从参照产品换药的患者其疗效和治疗结果是一致的。美国以外地区关于参照产品和阿达木单抗生物类似药转换的真实世界证据总体上反映了临床试验中观察到的情况;然而,真实世界证据的研究结果也阐明了生物类似药使用中存在的若干挑战,包括患者教育、医疗服务提供者培训和支持性政策。

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