Biosimilar Approval No Longer Requires Japanese Data in Bioequivalence Studies

According to the news “”BS同等性試験、民族差ない場合は日本人データ不要に  厚労省、Q&A改訂 | 日刊薬業 – 医薬品産業の総合情報サイト (“”  released by NIKKAN YAKUGYO on 25/1/2024, the Ministry of Health, Labour and Welfare announced a significant update to the regulatory framework for biosimilar approval. The “Questions and Answers (Q&A) on Guidelines for Ensuring the Quality, Safety and Efficacy of Biosimilar (BS)” in an administrative communication dated January 25, 2024, now clarifies that clinical trials enrolling Japanese subjects to verify the equivalence of BS with its predecessor are no longer mandatory if ethnic factors are deemed unlikely to influence the study outcomes. Consequently, clinical trial data from non-Japanese subjects can be used for regulatory approval. This change from the previous requirement, which mandated at least one of the clinical trials to verify the bioequivalence of pharmacokinetics and efficacy must enroll Japanese subjects, streamlines the development and approval process for biosimilars for international biotech and pharmaceutical companies aiming for the Japanese market.