Survey on the Role of Comparative Efficacy Studies Required for Biosimilar Monoclonal Antibody Approval in Japan to Justify the Quality Attribute Differences Between Biosimilars and Their Reference Products Based on the Pharmaceuticals and Medical Devices Agency (PMDA) Assessments
- DOI
- 10.1007/s40290-025-00583-w
- Published
- 2025-09-19
- Container
- Pharmaceutical Medicine
- Publisher
- Springer Science and Business Media LLC
- Open access
- unknown
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Cite this work
BibTeX
@article{allodium:10.1007/s40290-025-00583-w,
title = {Survey on the Role of Comparative Efficacy Studies Required for Biosimilar Monoclonal Antibody Approval in Japan to Justify the Quality Attribute Differences Between Biosimilars and Their Reference Products Based on the Pharmaceuticals and Medical Devices Agency (PMDA) Assessments},
author = {Kanoko Goto and Aya Hariu and Ryosuke Kuribayashi},
year = {2025},
journal = {Pharmaceutical Medicine},
doi = {10.1007/s40290-025-00583-w},
url = {https://doi.org/10.1007/s40290-025-00583-w}
}RIS
TY - JOUR TI - Survey on the Role of Comparative Efficacy Studies Required for Biosimilar Monoclonal Antibody Approval in Japan to Justify the Quality Attribute Differences Between Biosimilars and Their Reference Products Based on the Pharmaceuticals and Medical Devices Agency (PMDA) Assessments AU - Kanoko Goto AU - Aya Hariu AU - Ryosuke Kuribayashi PY - 2025 JO - Pharmaceutical Medicine DO - 10.1007/s40290-025-00583-w UR - https://doi.org/10.1007/s40290-025-00583-w ER -
APA
Goto, K., Hariu, A., & Kuribayashi, R. (2025). Survey on the Role of Comparative Efficacy Studies Required for Biosimilar Monoclonal Antibody Approval in Japan to Justify the Quality Attribute Differences Between Biosimilars and Their Reference Products Based on the Pharmaceuticals and Medical Devices Agency (PMDA) Assessments. Pharmaceutical Medicine. https://doi.org/10.1007/s40290-025-00583-w
Source records
- crossref · retrieved 2026-09-27T00:34:15.628Z