阿达木单抗注射液生物类似药临床试验设计考虑要点

Considerations of clinical trial design about adalimumab biosimilar

阿达木单抗是美国雅培公司原研的一种重组全人源化肿瘤坏死因子-α(tumor necrosis factor alpha,TNF-α)单克隆抗体注射液,在我国已获批用于类风湿关节炎、强直性脊柱炎和银屑病患者的治疗。目前,阿达木在欧盟和美国的专利已到期,因其国外获批适应证众多,已成为生物类似药的研发热点之一。本文将讨论阿达木单抗生物类似药的临床研究设计及相关审评考虑,以期促进国内阿达木单抗生物类似药的研发,提高临床研发效率。

Adalimumab is a recombinant fully humanized tumor necrosis factor alpha(TNF-α)monoclonal antibody injection,which was originally developed by Abbott Laboratories of the United States.It has been approved for rheumatoid arthritis,ankylosing spondylitis and psoriasispatients in China.Currently,the patients of adalimumab in the European Union and the United States have expired.Due to the large number of indications approved abroad,it has become one of hotspots of biosimilars.This article will discuss the clinical trials design and evaluation considerations of adalimumab biosimilars,in order to promote the research and development of adalimumab biosimilars and improve clinical research and development efficiency.