Solitano Virginia, D'Amico Ferdinando, Fiorino Gionata, Peyrin-Biroulet Laurent, Danese Silvio
Department of Biomedical Sciences, Humanitas University , Milan, Italy.
Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine , Vandoeuvre-lès-Nancy, France.
Expert Rev Clin Immunol. 2020 Oct;16(10):1019-1028. doi: 10.1080/1744666X.2021.1826311. Epub 2020 Sep 29.
After patents' expiration of biological originators, several biosimilars of infliximab and adalimumab have been authorized. The approval is based on data extrapolated from other indications for which the originator has been previously tested. Despite rigorous approval processes by regulatory entities, physicians' and patients' knowledge about biosimilars is limited and some concerns about their use persist.
This article summarizes the evidence on efficacy, safety, and immunogenicity of biosimilars currently approved in Europe for IBD treatment, by reviewing the literature on PubMed, EMBASE, and Web of Science databases up to mid-July 2020. Particular emphasis was placed on the need to further improve communication with patients and physicians' knowledge on biosimilars.
Adoption of biosimilars in clinical practice represents a great opportunity from an economic point of view, reducing healthcare costs and increasing patients' access to effective biologic treatments. Clinicians should be aware and confident of the latest evidence on available biosimilars and be very careful in communicating information to patients. Nocebo effect should not be overlooked since it can negatively influence outcomes of biosimilar-treated subjects, limiting the wide use of biosimilars. Evaluating the outcomes of reverse, multiple, and cross-switch will be a challenge for the next years.
在生物原研药专利到期后,几种英夫利昔单抗和阿达木单抗的生物类似药已获批准。批准是基于从原研药先前已测试的其他适应症外推的数据。尽管监管机构有严格的批准程序,但医生和患者对生物类似药的了解有限,对其使用仍存在一些担忧。
本文通过回顾截至2020年7月中旬在PubMed、EMBASE和科学网数据库上的文献,总结了目前在欧洲获批用于治疗炎症性肠病的生物类似药在疗效、安全性和免疫原性方面的证据。特别强调了进一步改善与患者的沟通以及医生对生物类似药知识的必要性。
从经济角度来看,在临床实践中采用生物类似药是一个巨大的机遇,可降低医疗成本并增加患者获得有效生物治疗的机会。临床医生应了解并确信有关现有生物类似药的最新证据,并在向患者传达信息时非常谨慎。不应忽视安慰剂效应,因为它会对接受生物类似药治疗的受试者的结果产生负面影响,限制生物类似药的广泛使用。评估反向、多次和交叉转换的结果将是未来几年的一项挑战。