Tabernero Josep, Vyas Malvika, Giuliani Rosa, Arnold Dirk, Cardoso Fatima, Casali Paolo G, Cervantes Andres, Eggermont Alexander M M, Eniu Alexandru, Jassem Jacek, Pentheroudakis George, Peters Solange, Rauh Stefan, Zielinski Christoph C, Stahel Rolf A, Voest Emile, Douillard Jean-Yves, McGregor Keith, Ciardiello Fortunato
Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona,.
European Society for Medical Oncology.
ESMO Open. 2017 Jan 16;1(6):e000142. doi: 10.1136/esmoopen-2016-000142. eCollection 2016.
Biosimilars present a necessary and timely opportunity for physicians, patients and healthcare systems. If suitably developed clinically, manufactured to the correct standards and used appropriately, they can positively impact on the financial sustainability of healthcare systems. A critical consideration regarding the introduction of biosimilars into the clinic centres on the required information concerning all the respective procedures. This position paper aims to describe the issues revolving around biosimilars that are relevant to the field of oncology, especially the prescribers. More specifically, we discuss aspects related to definition, forms of biosimilars, labelling, extrapolation, interchangeability, switching, automatic substitution, clinical standards on safety and efficacy, responsibilities among prescribers and pharmacists, potential impact on financial burden in healthcare and the current scenario and future prospects of biosimilars in Europe and the rest of the world.
生物类似药为医生、患者和医疗系统提供了一个必要且及时的契机。如果在临床上得到适当开发、按照正确标准生产并合理使用，它们可以对医疗系统的财务可持续性产生积极影响。将生物类似药引入临床的一个关键考量集中在有关所有各自程序的所需信息上。本立场文件旨在描述围绕生物类似药与肿瘤学领域相关的问题，尤其是开处方者。更具体地说，我们讨论与定义、生物类似药的形式、标签、外推法、可互换性、换药、自动替换、安全性和有效性的临床标准、开处方者和药剂师之间的责任、对医疗保健财务负担的潜在影响以及欧洲和世界其他地区生物类似药的当前情况和未来前景等方面。
