尽管曲妥珠单抗生物仿制药在全球范围内得到使用，但对其有效性和安全性的担忧仍然存在。特别是，当与帕妥珠单抗同时使用时，曲妥珠单抗生物仿制药缺乏广泛的真实数据和安全信息。此外，随着全球癌症药物支出持续增加，生物仿制药节省成本变得越来越重要。本研究旨在评估曲妥珠单抗原研药及其生物仿制药在真实临床环境中的安全性、有效性和成本效益，重点关注大量该分析包括来自日本 Medical Data Vision Co., Ltd. 数据库的 31,661 名 HER2 阳性乳腺癌患者。此外，从世界卫生组织的全球不良事件报告数据库 VigiBase 中获得了 58,799 名患者的曲妥珠单抗原研药及其生物仿制药的不良事件报告。在心力衰竭住院、肝功能障碍或输注反应率方面，两种药物均未观察到显着差异。 Medical Data Vision Co., Ltd. 数据库和世界卫生组织的 VigiBase。在医学数据视觉有限公司数据库中，帕妥珠单抗的添加并没有显着影响不良事件的发生率，并且生物类似药的使用显着降低了医疗费用，且乳腺癌复发率没有显着差异。通过分析两大以及来自多个角度的不同数据集，我们获得了可靠的结果，表明曲妥珠单抗原研药及其生物仿制药具有相似的安全性。同时使用帕妥珠单抗也被发现是安全的。使用生物仿制药可以节省成本。这些发现为临床实践中生物仿制药的评估和采用提供了重要的见解。© 2024。作者。

Despite the global use of trastuzumab biosimilars, concerns remain regarding their efficacy and safety. In particular, when used concurrently with pertuzumab, trastuzumab biosimilars lack extensive real-world data and safety information. Additionally, as cancer drug expenditures continue to rise worldwide, cost savings from biosimilars have become increasingly important.This study aims to assess the safety, efficacy, and cost effectiveness of trastuzumab originators and their biosimilars in real-world clinical settings, focusing on a large patient population.The analysis included 31,661 patients with HER2-positive breast cancer from the Medical Data Vision Co., Ltd. database in Japan. Additionally, adverse event reports for the trastuzumab originator and its biosimilars were obtained for 58,799 patients from the World Health Organization's VigiBase, the global adverse event reporting database.No significant differences were observed in heart failure hospitalizations, liver dysfunction, or infusion reaction rates in both the Medical Data Vision Co., Ltd. database and the World Health Organization's VigiBase. In the Medical Data Vision Co., Ltd. database, the addition of pertuzumab did not significantly influence the incidence of adverse events, and the use of biosimilars significantly reduced medical costs, with no significant difference in breast cancer recurrence rates.By analyzing two large and diverse datasets from multiple perspectives, we obtained reliable results that the trastuzumab originator and its biosimilars have similar safety profiles. The concurrent use of pertuzumab was also found to be safe. The use of biosimilars can lead to cost savings. These findings provide crucial insights for the evaluation and adoption of biosimilars in clinical practice.© 2024. The Author(s).