Department of Breast Oncology, National Hospital Organization Shikoku Cancer Center, Ehime, Japan.
Medical Affairs, Pfizer Japan Inc., Tokyo, Japan.
Future Oncol. 2019 Apr;15(12):1353-1361. doi: 10.2217/fon-2018-0957. Epub 2019 Feb 15.
Biologics have dramatically changed breast cancer treatment, and trastuzumab has been an essential treatment drug for HER2-positive breast cancer. The introduction of trastuzumab biosimilar offers the potential to deliver long-term cost savings plus efficiencies for healthcare systems in Japan. The goal of biosimilar development is to demonstrate comparability to the original biologic with a different development concept from that of the original biologic. Hence, a better understanding of the biosimilar itself is urgently needed for appropriate adoption and the integration of trastuzumab biosimilars into oncology clinical practice by all stakeholders. This article focuses on the current situation of biosimilars and future perspectives in Japan by using the trastuzumab biosimilar as an example.
生物制剂极大地改变了乳腺癌的治疗方式，曲妥珠单抗已成为治疗 HER2 阳性乳腺癌的重要药物。曲妥珠单抗生物类似药的引入有望为日本的医疗保健系统带来长期的成本节约和效率提升。生物类似药开发的目标是通过与原生物制品不同的开发理念来证明与原生物制品的可比性。因此，所有利益相关者都迫切需要更好地了解生物类似药本身，以便适当采用并将曲妥珠单抗生物类似药整合到肿瘤学临床实践中。本文以曲妥珠单抗生物类似药为例，聚焦日本生物类似药的现状和未来展望。
