Oregon Medical Research Center, Portland, OR, U.S.A.
Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
Br J Dermatol. 2017 Jul;177(1):23-33. doi: 10.1111/bjd.15067. Epub 2017 May 28.
Biosimilars are drugs that are similar, but not identical, to originator biologics. Preclinical analytical studies are required to show similarity on a molecular and structural level, but efficacy and safety studies in humans are essential to determining biosimilarity. In this review, written by members of the International Psoriasis Council, we discuss how biosimilars are evaluated in a clinical setting, with emphasis on extrapolation of indication, interchangeability and optimal clinical trial design.
生物类似药是指在分子水平和结构水平上与原创生物药相似但不完全相同的药物。需要进行临床前分析研究以显示其相似性，但在人体中进行疗效和安全性研究对于确定生物类似药的相似性至关重要。在这篇由国际银屑病理事会成员撰写的综述中，我们讨论了生物类似药在临床环境中的评估方法，重点讨论了适应证的外推、可互换性和最佳临床试验设计。
