Documento de consenso sobre los medicamentos biosimilares en enfermedades inmunomediadas en España

IF 1.2 Q4 RHEUMATOLOGY

Reumatologia Clinica Pub Date : 2023-10-01 DOI:10.1016/j.reuma.2022.12.001

Emilio Monte-Boquet , Ángeles Florez , Guillermo José Alcaín Martínez , Agustí Sellas

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Abstract

Objective

To improve knowledge about biosimilar medicines and to generate a consensus framework on their use.

Methods

Qualitative study. A multidisciplinary group of experts in biosimilar medicines was established (1 dermatologist, 1 hospital pharmacist, 1 rheumatologist, and 1 gastroenterologist) who defined the sections and topics of the document. A narrative literature review was performed in Medline to identify articles on biosimilar medicines. Systematic reviews, controlled, pre-clinical, clinical, and real-life studies were selected. Based on the results of the review, several general principles and recommendations were generated. The level of agreement was tested in a Delphi that was extended to 66 health professionals who voted from 1 (totally disagree) to 10 (totally agree). Agreement was defined if at least 70% of the participants voted ≥ 7.

Results

The literature review included 555 articles. A total of 10 general principles and recommendations were voted upon. All reached the level of agreement established. The document includes data on the main characteristics of biosimilar medicines (definition, development, approval, indication extrapolation, interchangeability, financing, and traceability); published evidence (biosimilarity, efficacy, effectiveness, safety, immunogenicity, efficiency, switch); barriers and facilitators to its use; and data on information for patients.

Conclusions

Authorized biosimilar medicines meet all the characteristics of quality, efficacy, and safety. They also significantly help improve patient access to biological therapies and contribute to health system sustainability.

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关于西班牙免疫介导疾病中生物仿制药的共识文件

目的提高对生物类似药的认识，形成生物类似药使用的共识框架。MethodsQualitative研究。建立了一个多学科的生物仿制药专家组(1名皮肤科医生、1名医院药剂师、1名风湿病专家和1名胃肠病学专家)，他们定义了文件的章节和主题。在Medline上进行了一项叙述性文献综述，以确定有关生物仿制药的文章。系统评价，对照，临床前，临床和现实生活的研究被选择。根据审查结果，提出了若干一般原则和建议。同意程度在德尔菲测试中被扩展到66名卫生专业人员，他们从1(完全不同意)到10(完全同意)投票。如果至少70%的参与者投票≥7，则定义为同意。结果共纳入文献555篇。总共就10项一般原则和建议进行了表决。都达到了既定的协议水平。该文件包括关于生物类似药主要特征的数据(定义、开发、批准、适应症外推、互换性、融资和可追溯性);已发表的证据(生物相似性、疗效、有效性、安全性、免疫原性、效率、开关);使用的障碍和促进因素;以及患者信息的数据。结论已获批的生物仿制药在质量、疗效和安全性方面均满足要求。它们还显著有助于改善患者获得生物疗法的机会，并有助于卫生系统的可持续性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Reumatologia Clinica RHEUMATOLOGY-

CiteScore

2.40

自引率

6.70%

发文量

105

审稿时长

54 days

期刊介绍： Una gran revista para cubrir eficazmente las necesidades de conocimientos en una patología de etiología, expresividad clínica y tratamiento tan amplios. Además es La Publicación Oficial de la Sociedad Española de Reumatología y del Colegio Mexicano de Reumatología y está incluida en los más prestigiosos índices de referencia en medicina.