注射用曲妥珠单抗生物类似药临床研究设计及审评考虑要点

Clinical study design on trastuzumab biosimilar and relevant evaluation considerations

曲妥珠单抗是一种重组DNA衍生的人源化单克隆抗体,在我国已获批用于人表皮生长因子受体-2阳性乳腺癌和胃癌患者的治疗。近年来,随着曲妥珠单抗在欧盟和美国的专利到期,其生物类似药的研发成为热点。本文着重讨论曲妥珠单抗生物类似药的临床研究策略和方案设计要点及相关审评考虑,以期为我国曲妥珠单抗生物类似药的研发提供参考。

Trastuzumab,a recombinant DNA-derived humanized monoclonal antibody,which has been approved for the treatment of breast cancer and gastric cancer patients with human epidermal growth factor receptor-2(HER-2)-positive in China.Recently,the patent of trastuzumab has expired in European Union and the United States.Trastuzumab become one of the hotspots in the field of biosimilar drugs.This article focuses on the research strategy and clinical trial design of trastuzumab biosimilar,along with the considerations about data needed for evaluation of these drugs,hoping to provide references for the development of trastuzumab biosimilar in China.