托珠单抗注射液生物类似药临床试验设计要点的审评考虑

Evaluation considerations of clinical trial design key points about tocilizumab biosimilar

托珠单抗注射液是一种人源化抗人白细胞介素6受体单克隆抗体制剂,在我国已获批用于成人类风湿关节炎、全身型幼年特发性关节炎患者。因原研产品分子保护专利已到期,该品种已成为生物类似药的研发热点之一。目前,境内外尚无托珠单抗注射液生物类似药上市。本文将从审评视角探讨该品种生物类似药的临床研究设计要点,以期为托珠单抗生物类似药的临床研发提供参考。

Tocilizumab is a humanized monoclonal antibody against human interleukin-6 receptor.It has been approved for the treatment of adult rheumatoid arthritis and systemic juvenile idiopathic arthritis in our country.Because the molecular protection patent of the product has expired,it has become one of the hotspots in the field of biosimilars.At present,there’s no biosimilars for tocilizumab on the market at home and abroad.This article will discuss the design key points and related evaluation of clinical research design for tocilizumab biosimilar from the perspective of evaluation,in order to provide references for the development of tocilizumab biosimilar.