Cai Xiao-Yan, Thomas Jeff, Cullen Constance, Gouty Dominique
Department of Biologics Bioanalytical, Merck, 1011 Morris Avenue, NJ 07083, USA.
Bioanalysis. 2012 Sep;4(17):2169-77. doi: 10.4155/bio.12.185.
Imminent patent expiry for a number of biological products currently on the market (many of which are blockbusters) has created an increasing opportunity for the development of biosimilars in the biotechnology industry. The key for successful biosimilar development is to demonstrate biosimilarity to the originator drug. In addition to demonstrating the similarity of physical and chemical properties between biosimilar and originator compounds, regulatory agencies require that immunogenicity be evaluated in comparative studies between biosimilar and originator drugs. Immunogenicity assays are generally non-quantitative (qualitative) and proving similarity/comparability based on qualitative assays can be very challenging. This review will discuss the challenges of developing and validating immunogenicity assays to support preclinical and clinical comparative studies for biosimilar drug development as well as the challenges in association with the interpretation of the data.
目前市场上多种生物制品（其中许多是畅销药）即将面临专利到期，这为生物技术行业生物类似药的开发创造了越来越多的机会。成功开发生物类似药的关键在于证明其与原研药的生物相似性。除了证明生物类似药与原研药化合物之间物理和化学性质的相似性外，监管机构还要求在生物类似药与原研药的对比研究中评估免疫原性。免疫原性检测通常是非定量的（定性的），基于定性检测来证明相似性/可比性可能极具挑战性。本综述将讨论开发和验证免疫原性检测以支持生物类似药开发的临床前和临床对比研究的挑战，以及与数据解读相关的挑战。
