Office of Cellular and Tissue-Based Products Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan.
BioDrugs. 2023 Jul;37(4):443-451. doi: 10.1007/s40259-023-00605-6. Epub 2023 May 25.
A biosimilar product is defined as "a biological product that is highly similar to an existing, approved biological product (known as originator or reference product) in terms of structure, function, quality, and clinical efficacy and safety". Recently, biosimilar products have been actively developed around the world, and part of the reason for this is to combat the rapid growth of medical expenses in many countries, including Japan, the United States (US), and Europe. The use of biosimilar products has been promoted as a measure to address this issue. The review of marketing authorization applications for biosimilar products in Japan is conducted by the Pharmaceuticals and Medical Devices Agency (PMDA), which reviews the comparability of the quality, efficacy, and safety based on the data submitted by the applicants. As of December 2022, 32 biosimilar products have been approved in Japan. Through this process, the PMDA has gained much experience and knowledge regarding the development and regulatory approval of biosimilar products; however, details of the regulatory approvals for biosimilar products in Japan have not been reported until now. Therefore, in this article, we present the details of regulatory history and revised guidelines for approval of biosimilar products in Japan, questions and answers, other relevant notifications, and consideration for comparability evaluations for analytical, non-clinical, and clinical studies. In addition, we provide details about the approval history, number, and types of biosimilar products that have been approved between 2009 and 2022 in Japan.
生物类似药是指“在结构、功能、质量、临床疗效和安全性方面与已批准的现有生物制品（称为原研药或参照药）高度相似的生物制品”。最近，全球范围内积极开发生物类似药，部分原因是为了应对包括日本、美国和欧洲在内的许多国家医疗费用的快速增长。使用生物类似药被视为解决这一问题的一项措施。日本药品和医疗器械管理局（PMDA）对生物类似药的营销授权申请进行审查，根据申请人提交的数据，审查其质量、疗效和安全性的可比性。截至 2022 年 12 月，日本已批准 32 种生物类似药。通过这一过程，PMDA 在生物类似药的开发和监管审批方面积累了丰富的经验和知识；然而，直到现在，日本生物类似药监管审批的详细信息尚未报道。因此，本文介绍了日本生物类似药监管审批的历史和修订指南、问答、其他相关通知，以及对分析、非临床和临床研究可比性评估的考虑。此外，还详细介绍了日本在 2009 年至 2022 年期间批准的生物类似药的批准历史、数量和类型。
