ABSTRACT

Introduction

The introduction of biosimilars into our therapeutic arsenal has revolutionized the accessibility of biological treatments to patients with psoriasis, mainly from an economic standpoint. At this point, it is interesting to assess what their current positioning is.

Areas covered

A bibliographic review has been carried out that includes the technical sheets of the different drugs, criteria for the use of biosimilars, the current situation of the main prescribing countries, and data on actual clinical practice in the period 2015–2020 using the Pubmed® and Embase databases. ®.Accessibility varies from country to country, regardless of the standards set by the Food and Drug Administration (FDA) or European Medicines Agency (EMA), owing to the need for biosimilars to be submitted for approval to local regulatory agencies. The switching/interchangeability/substitution criteria are not homogeneous, with variable outcomes ranging from clinical trials (for example, Norway) to mere non-binding recommendations.

Expert Opinion

The use of biosimilars is appropriate for a high percentage of patients. Its position as first-line drugs compared to traditional systemic drugs and the new anti-IL molecules must be reviewed since clinical choice cannot be based on economic aspects only.

中文翻译：

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牛皮癣中的生物仿制药：您的定位应该是什么？

摘要

介绍

主要从经济角度来看，将生物仿制药引入我们的治疗库已经彻底改变了银屑病患者生物治疗的可及性。在这一点上，评估他们当前的定位是很有趣的。

涵盖的领域

已经进行了书目审查，包括不同药物的技术表、生物仿制药的使用标准、主要处方国家的现状以及使用 Pubmed® 和 2015-2020 年期间的实际临床实践数据。嵌入数据库。®.可及性因国家而异，无论食品和药物管理局 (FDA) 或欧洲药品管理局 (EMA) 制定的标准如何，因为生物仿制药需要提交给当地监管机构批准。转换/互换性/替代标准不是同质的，从临床试验（例如，挪威）到单纯的不具约束力的建议，结果各不相同。

专家意见

生物仿制药的使用适用于大部分患者。由于临床选择不能仅基于经济方面，因此必须审查其与传统全身药物和新型抗 IL 分子相比作为一线药物的地位。