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<p>The Pharmaceuticals and Medical Devices Agency (PMDA) is a Japanese authority responsible for reviewing the quality, efficacy, and safety of drugs and medical devices to be marketed for public health protection. This study investigated the approval numbers of monoclonal antibodies (mAbs). In addition, it classified canonical and modified antibodies, such as antibody–drug conjugates (ADCs), antibody fragments, and bispecific antibodies (bsAb), excluding the biosimilar versions of mAbs in each fiscal year (FY) based on the PMDA website (<CitationRef CitationID="CR1">1</CitationRef>). Moreover, the approval FY data, brand names, international nonproprietary names, cell substrates, targets, disease areas at initial approval, and regulatory pathways were compiled (Supplement Document <InternalRef RefID="MOESM1">1</InternalRef>).</p>

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The 100th Monoclonal Antibody Product is Approved in Japan

  • 期刊论文

  • 发表日期：

    2025年6月4日

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  • Aya Hariu,
  • Yukiko Shirahata,
  • Kayo Shinohara,
  • Ryosuke Kuribayashi

摘要

The Pharmaceuticals and Medical Devices Agency (PMDA) is a Japanese authority responsible for reviewing the quality, efficacy, and safety of drugs and medical devices to be marketed for public health protection. This study investigated the approval numbers of monoclonal antibodies (mAbs). In addition, it classified canonical and modified antibodies, such as antibody–drug conjugates (ADCs), antibody fragments, and bispecific antibodies (bsAb), excluding the biosimilar versions of mAbs in each fiscal year (FY) based on the PMDA website (1). Moreover, the approval FY data, brand names, international nonproprietary names, cell substrates, targets, disease areas at initial approval, and regulatory pathways were compiled (Supplement Document 1).