ABSTRACT

Introduction

Five years after the launch of the first infliximab biosimilar, biologics have found their place in the treatment of chronic inflammatory conditions, but there are remaining questions. This is a review of the introduction of antibody biosimilars in Europe; the reasons for their success and how biosimilar hesitancy was quailed.

Areas covered

We provide an overview of the concepts of biosimilarity, extrapolation, and interchangeability, using examples in rheumatology and gastroenterology for illustration. A review of the evidence collected from switching studies using robust designs is included. Remaining questions such as ‘inter-switching’ are also discussed.

Expert opinion

Biosimilars have democratized access to powerful medicines. Efficacy and safety studies provided reassuring data, but knowledge gaps persist. The availability of so-called ‘bio-betters’ might open new avenues and change clinical practice.

中文翻译：

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慢性炎症性疾病中的生物仿制药：在欧洲推出 5 年后的事实和遗留问题

摘要

介绍

在第一个英夫利昔单抗生物仿制药上市五年后，生物制剂已在慢性炎症疾病的治疗中找到了自己的位置，但仍存在一些问题。这是对欧洲引入抗体生物类似药的回顾；他们成功的原因以及生物仿制药的犹豫是如何被吓倒的。

涵盖的领域

我们使用风湿病学和胃肠病学中的示例来概述生物相似性、外推和互换性的概念。包括使用稳健设计从转换研究中收集的证据的审查。还讨论了诸如“相互转换”之类的剩余问题。

专家意见

生物仿制药使获得强效药物的途径民主化。功效和安全性研究提供了令人放心的数据，但知识差距仍然存在。所谓的“生物更好”的可用性可能会开辟新的途径并改变临床实践。