Hariu Aya, Saino Yuka, Kuribayashi Ryosuke
Office of Cellular and Tissue-Based Products, Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan.
Office of Regulatory Science Research, Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan.
Naunyn Schmiedebergs Arch Pharmacol. 2025 Aug 13. doi: 10.1007/s00210-025-04494-0.
The first biosimilar was approved in April 2006 in the EU, June 2009 in Japan, and March 2015 in the USA. However, a detailed comparison and trend analysis of the biosimilar approvals by the three agencies has not been reported. It is important to understand current biosimilar approval status, biosimilar drug lag, and drug loss (i.e., biosimilar void) for considering this impact and avoiding the biosimilar lag and loss as much as possible in the future. We surveyed the biosimilar approval information from the websites of Japan's Pharmaceuticals and Medical Devices Agency (PMDA), the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA) regarding the reference product, nonproprietary name, brand name, type of biologics, and approval date. Furthermore, we calculated the differences in timing of biosimilar approval among the three agencies (biosimilar lag) and surveyed the publicly available data based on the ClinicalTrials.gov for the consideration of reference products not subject to biosimilar development (biosimilar loss). The Ministry of Health, Labour and Welfare/PMDA, the US FDA, and the EMA have approved 38, 69, and 125 biosimilars until March 2025, respectively. The biosimilar lag increased among Japan, the USA, and the EU, and recently expanded in Japan in comparison with the USA and the EU. Moreover, our survey indicated 29 candidates for biosimilar loss and 16 active drug substances being orphan drugs. Biosimilar development has been expanding in Japan, the USA, and the EU. Our findings reveal a clear expansion of the biosimilar lag for the delay in Japan and may also explain the biosimilar loss for some potential biosimilars.
首个生物类似药于2006年4月在欧盟获批，2009年6月在日本获批，2015年3月在美国获批。然而，尚未有关于这三个机构生物类似药获批情况的详细比较和趋势分析的报道。了解当前生物类似药的获批状况、生物类似药滞后情况以及药物缺失（即生物类似药空白）对于考虑这种影响并尽可能避免未来生物类似药滞后和缺失至关重要。我们从日本药品和医疗器械管理局（PMDA）、美国食品药品监督管理局（FDA）以及欧洲药品管理局（EMA）的网站上调查了生物类似药的获批信息，内容涉及参照产品、通用名、商品名、生物制品类型以及获批日期。此外，我们计算了这三个机构在生物类似药获批时间上的差异（生物类似药滞后），并基于美国国立医学图书馆临床试验数据库（ClinicalTrials.gov）调查了公开可用数据，以考虑未进行生物类似药研发的参照产品（生物类似药缺失）。截至2025年3月，日本厚生劳动省/PMDA、美国FDA和EMA分别批准了38种、69种和125种生物类似药。日本、美国和欧盟之间的生物类似药滞后情况有所增加，并且最近与美国和欧盟相比，日本的滞后情况有所扩大。此外，我们的调查表明有29种生物类似药缺失候选产品，并且有16种活性药物成分是孤儿药。生物类似药的研发在日本、美国和欧盟一直在扩大。我们的研究结果揭示了日本生物类似药滞后情况明显扩大，这也可能解释了一些潜在生物类似药的生物类似药缺失情况。
