从阿达木单抗参考产品切换到美国以外的阿达木单抗生物类似药:对美国临床医生的见解

IF 5.4 2区 医学 Q1 IMMUNOLOGY
John R P Tesser, Aline Charabaty, Adelaide A Hebert
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引用次数: 0

摘要

自2023年以来,已有10种阿达木单抗生物类似药在美国上市,而阿达木单抗生物类似药在其他国家已经上市数年。这些在美国以外使用生物仿制药的经验可以为美国的医疗保健专业人员提供在现实生活实践环境中转换的信息。考虑因素包括医疗保健专业人员如何有效地解决患者对结果的担忧,以提高患者满意度。对MEDLINE数据库的搜索用于识别前美国环境中切换到阿达木单抗生物类似药的出版物,没有出版语言限制,使用的时间框架为2017年1月1日至2023年12月12日,与欧盟于2017年3月批准首个阿达木单抗生物类似药adalimumab-atto一致。本叙述性综述旨在从临床研究中深入了解成人患者过渡到阿达木单抗生物类似药的有效性和安全性,但更重要的是,使用来自美国以外的真实世界证据(RWE)。总的来说,RWE表明,在各种免疫介导的炎症疾病中,与未从RP切换的患者相比,从参考产品(RP)切换的患者的疗效和结果是一致的。RP和阿达木单抗生物仿制药切换的前美国RWE通常反映了临床试验中观察到的经验;然而,RWE的研究结果阐明了生物仿制药吸收的几个挑战,包括患者教育、提供者培训和支持政策。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Switching from Adalimumab Reference Product to and Among Adalimumab Biosimilars Outside the USA: Insights for US Clinicians.

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.

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来源期刊
BioDrugs
BioDrugs 医学-免疫学
CiteScore
12.60
自引率
2.90%
发文量
50
审稿时长
>12 weeks
期刊介绍: An essential resource for R&D professionals and clinicians with an interest in biologic therapies. BioDrugs covers the development and therapeutic application of biotechnology-based pharmaceuticals and diagnostic products for the treatment of human disease. BioDrugs offers a range of additional enhanced features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by a Key Points summary, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist patients, caregivers and others in understanding important medical advances. The journal also provides the option to include various other types of enhanced features including slide sets, videos and animations. All enhanced features are peer reviewed to the same high standard as the article itself. Peer review is conducted using Editorial Manager®, supported by a database of international experts. This database is shared with other Adis journals.
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