阿达木单抗生物类似药临床药代动力学比对研究的指导原则解读和文献综述  

Elaboration of different regulatory guidance regarding comparative pharmacokinetic study with adalimumab biosimilars and case studies through relevant publications

作　　者：陈霞 钟文[3] 王松 CHEN Xia;ZHONG Wen;WANG Song(China National Clinical Research Center for Neurological Diseases/Beijing Tiantan Hospital,Capital Medical University,Beijing 100070,China;Advanced Innovation Center for Human Brain Protection,Capital Medical University,Beijing 100070,China;Clinical Pharmacology Research Center,Peking Union Medical College Hospital,Beijing 100032,China)

机构地区：[1]首都医科大学附属北京天坛医院国家神经系统疾病临床医学研究中心,北京100070 [2]首都医科大学人脑保护高精尖创新中心,北京100070 [3]北京协和医院临床药理研究中心,北京100032

出　　处：《中国临床药理学杂志》2020年第20期3377-3382,共6页The Chinese Journal of Clinical Pharmacology

摘　　要：本文将中国国家药品监督管理局发布的阿达木单抗生物类似药的个药临床试验指导原则与美、欧两个监管机构发布的有关单抗类生物类似药的相关指导原则进行比较和解读。通过综述已发表的8种不同阿达木单抗生物类似药与原研产品的生物等效性研究,结合阿达木单抗的群体药代动力学特征,总结了阿达木单抗生物类似药药代动力学比对研究的设计策略和实施要素。This manuscript compares the clinical trial guideline for adalimumab biosimilars issued by China National Medical Products Administration and relevant guidance for monoclonal antibody biosimilars that are published by FDA and EMA.The authors review eight published bioequivalence studies with different adalimumab biosimilars and the original biological drug as reference,in conjunction with the population pharmacokinetic analysis about adalimumab.The purpose is to summarize design strategies and critical implementation points for future comparative pharmacokinetic studies with adalimumab biosimilars.

关 键 词：阿达木单抗 生物类似药 药代动力学比对研究 

分 类 号：R97[医药卫生—药品]