ABSTRACT

Introduction

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.

Areas covered

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.

Expert opinion

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.

中文翻译：

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炎症性肠病的生物仿制药转换：从证据到临床实践。

摘要

介绍

在生物原研药专利到期后，英夫利昔单抗和阿达木单抗的多个生物仿制药获得了授权。该批准基于从原研药先前已测试过的其他适应症中推断出的数据。尽管监管机构有严格的审批程序，但医生和患者对生物仿制药的了解是有限的，并且对其使用的一些担忧仍然存在。

覆盖区域

本文通过回顾截至 2020 年 7 月中旬的 PubMed、EMBASE 和科学数据库中的文献，总结了目前在欧洲批准用于 IBD 治疗的生物仿制药的有效性、安全性和免疫原性的证据。特别强调了需要进一步改善与患者和医生的生物仿制药知识交流。

专家意见

从经济角度来看，生物仿制药在临床实践中的采用代表了一个巨大的机会，可以降低医疗成本并增加患者获得有效生物治疗的机会。临床医生应该了解可用生物仿制药的最新证据并对此充满信心，并在向患者传达信息时要非常小心。反安慰剂效应不容忽视，因为它会对生物仿制药治疗受试者的结果产生负面影响，从而限制了生物仿制药的广泛使用。评估反向、多重和交叉转换的结果将是未来几年的挑战。