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<p>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.</p>

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Consideration of the biosimilar drug lag and loss among Japan, the USA, and the EU

  • 期刊论文

  • 发表日期：

    2025年8月13日

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  • Aya Hariu,
  • Yuka Saino,
  • Ryosuke Kuribayashi

摘要

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.