Puig L, Carretero G, Daudén E, Ferrándiz C, Marrón S E, Martorell A, Pérez-Suárez B, Rodriguez-Cerdeira C, Ruiz-Villaverde R, Sánchez-Carazo J L, Velasco M
Servicio de Dermatología, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, España.
Servicio de Dermatología, Hospital Universitario de Gran Canaria Doctor Negrín , Las Palmas de Gran Canaria, España.
Actas Dermosifiliogr. 2015 Sep;106(7):545-9. doi: 10.1016/j.ad.2015.04.006. Epub 2015 May 16.
The first biosimilar version of a biologic agent used to treat psoriasis (infliximab) entered the Spanish market on February 16 of this year, and more biosimilars can be expected to follow in the coming months and years. Logically, this new situation will have economic repercussions and alter prescribing patterns among dermatologists. In this article, we review regulatory issues related to the approval of biosimilars, with a particular focus on the situation in the European Union. We will examine analytical characterization studies and special considerations for clinical trials with biosimilars, and also look at several somewhat contentious issues, such as the extrapolation of indications, interchangeability, and automatic substitution. Finally, we will review the biosimilars with indications for psoriasis currently in the clinical development pipeline and assess their potential to offer comparable efficacy and safety to the reference product while contributing to the sustainability of the public health care system.
用于治疗银屑病的生物制剂（英夫利昔单抗）的首个生物类似药版本于今年2月16日进入西班牙市场，预计在未来几个月和几年内会有更多生物类似药接踵而至。顺理成章地，这种新情况将产生经济影响，并改变皮肤科医生的处方模式。在本文中，我们回顾了与生物类似药批准相关的监管问题，特别关注欧盟的情况。我们将研究生物类似药的分析特性研究和临床试验的特殊考量因素，还将探讨几个颇具争议的问题，如适应症外推、可互换性和自动替换。最后，我们将回顾目前处于临床开发阶段的有银屑病适应症的生物类似药，并评估它们在提供与参比产品相当的疗效和安全性同时，对公共医疗保健系统可持续性做出贡献的潜力。
