Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
摘要：
■关于日本生物仿制药指南的“问答（Q&A）”文件阐明，在日本，生物仿制药的上市许可申请（MAA）需要日本参与者参加至少一项比较临床研究。
■为了讨论日本临床研究数据对生物仿制药开发的要求，分析了对已批准的单克隆抗体和融合蛋白生物仿制药进行的比较临床研究的趋势，并根据公开信息审查了总体人群和日本人群之间的结果一致性。
■招募日本参与者的比较临床研究数量为25例，比较药代动力学研究和比较疗效研究的类型和百分比分别为13例（52％）和12例（48％），分别。在所有比较临床研究中，显示了总体人口和日本人口之间的一致结果。
■我们的研究表明，在满足某些条件的情况下，日本参与者参加比较临床研究并不总是生物仿制药开发所必需的。卫生部发布的修订后的问答文件中对此进行了描述，2024年1月劳动和福利。
■为了讨论日本临床研究数据对生物仿制药开发的要求，分析了对已批准的单克隆抗体和融合蛋白生物仿制药进行的比较临床研究的趋势，并根据公开信息审查了总体人群和日本人群之间的结果一致性。
■招募日本参与者的比较临床研究数量为25例，比较药代动力学研究和比较疗效研究的类型和百分比分别为13例（52％）和12例（48％），分别。在所有比较临床研究中，显示了总体人口和日本人口之间的一致结果。
■我们的研究表明，在满足某些条件的情况下，日本参与者参加比较临床研究并不总是生物仿制药开发所必需的。卫生部发布的修订后的问答文件中对此进行了描述，2024年1月劳动和福利。
