Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan.

IF 3.6 3区医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Expert Opinion on Biological Therapy Pub Date : 2024-07-01 Epub Date: 2024-07-09 DOI:10.1080/14712598.2024.2377300

Ryosuke Kuribayashi, Kanoko Goto, Aya Hariu, Yasuhiro Kishioka

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Abstract

Background: The 'Questions and Answers (Q&A)' document regarding Japanese biosimilar guideline elucidated that Japanese participant enrollment in at least one comparative clinical study was required for the marketing authorization application (MAA) of biosimilars in Japan.

Research design and methods: To discuss the requirement of Japanese clinical study data for biosimilar development, the trend in comparative clinical studies conducted for approved biosimilars of monoclonal antibodies and fusion proteins was analyzed, and the consistency of the results between the overall population and the Japanese population according to the publicly available information was reviewed.

Results: The number of comparative clinical studies enrolling Japanese participants was 25 cases, and the type and percentage were 13 (52%) and 12 (48%) cases of comparative pharmacokinetic study and comparative efficacy study, respectively. In all comparative clinical studies, consistent results between the overall population and the Japanese population were shown.

Conclusions: Our study indicated that Japanese participant enrollment in comparative clinical studies may not always be necessary for biosimilar development when certain conditions are satisfied. This has been described in the revised Q&A document published by the Ministry of Health, Labour and Welfare in January 2024.

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修订日本生物仿制药开发对日本临床研究数据的要求。

背景：有关日本生物仿制药指南的 "问与答（Q&A）"文件阐明，在日本申请生物仿制药的上市许可（MAA）需要至少有一项比较临床研究的日本参与者参与：为了讨论生物仿制药开发对日本临床研究数据的要求，我们分析了已获批准的单克隆抗体和融合蛋白生物仿制药的比较临床研究趋势，并根据公开信息回顾了总体人群和日本人群的结果一致性：结果：纳入日本参与者的比较临床研究有 25 例，药代动力学比较研究和药效比较研究的类型和比例分别为 13 例（52%）和 12 例（48%）。在所有比较临床研究中，总体人群与日本人群的结果一致：我们的研究表明，在满足某些条件的情况下，生物类似药的开发并不一定需要日本人参与比较临床研究。厚生劳动省在 2024 年 1 月发布的修订版问答文件中对此进行了说明。

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来源期刊

Expert Opinion on Biological Therapy 医学-生物工程与应用微生物

CiteScore

8.60

自引率

0.00%

发文量

审稿时长

3-8 weeks

期刊介绍： Expert Opinion on Biological Therapy (1471-2598; 1744-7682) is a MEDLINE-indexed, international journal publishing peer-reviewed research across all aspects of biological therapy. Each article is structured to incorporate the author’s own expert opinion on the impact of the topic on research and clinical practice and the scope for future development. The audience consists of scientists and managers in the healthcare and biopharmaceutical industries and others closely involved in the development and application of biological therapies for the treatment of human disease. The journal welcomes: Reviews covering therapeutic antibodies and vaccines, peptides and proteins, gene therapies and gene transfer technologies, cell-based therapies and regenerative medicine Drug evaluations reviewing the clinical data on a particular biological agent Original research papers reporting the results of clinical investigations on biological agents and biotherapeutic-based studies with a strong link to clinical practice Comprehensive coverage in each review is complemented by the unique Expert Collection format and includes the following sections: Expert Opinion – a personal view of the data presented in the article, a discussion on the developments that are likely to be important in the future, and the avenues of research likely to become exciting as further studies yield more detailed results; Article Highlights – an executive summary of the author’s most critical points.