曲妥珠单抗生物仿制药治疗HER-2阳性乳腺癌的临床研究进展

近年来，研究证明曲妥珠单抗可以显著改善人表皮生长因子受体-2（human epidermal growthfactor receptor 2，HER-2）阳性乳腺癌患者的生存预后，但由于其价格高昂，使患者选择受限。曲妥珠单抗生物仿制药的诞生有望节约成本、增加药物可及性，近年来已得到迅速发展。YL-1401O（Ogivri）、CT-P6（Herzuma）、SB3（Ontruzant）、PF-05280014（Trazimera）和ABP980（Kanjinti），它们现已被美国食品药品监督管理局（Food and Drug Administration，FDA）批准用于HER-2阳性乳腺癌；我国HLX02已被欧洲药品管理局（The European Medicines Agency，EMA）和国家药品监督管理局（National Medical Products Administration，NMPA）批准上市。本文就近几年曲妥珠单抗生物仿制药在HER-2阳性乳腺癌中的研究进展进行综述,以期为HER-2阳性乳腺癌的靶向治疗提供参考。

Clinical research progress of trastuzumab biosimilars in HER-2 positive breast cancer

In recent years,studies have shown that trastuzumab can significantly improve for the survival of patients with human epidermal growth factor receptor 2(HER-2) positive breast cancer.Due to its high cost,make the patient choice is limited.Trastuzumab biosimilars,which are expected to reduce costs and increase access to drugs,have developed rapidly in recent years.YL-1401O(Ogivri),CT-P6(Herzuma),SB3(Ontruzant),PF-05280014(Trazimera)and ABP980(Kanjinti) have been approved by the U.S.Food and Drug Administration for HER-2 positive breast cancer.HLX02 has been approved for marketing by The European Medicines Agency(EMA) and National Medical Products Administration(NMPA) in China.In this paper,the research progress of trastuzumab biosimilar in HER-2 positive breast cancer was reviewed in recent years,in order to provide reference for targeted therapy of HER-2 positive breast cancer.