Survey of Data Package and Sample Size of Comparative Clinical Studies for Biosimilar Developments from PMDA Assessments-Reference-Cited by-同舟云学术

Survey of Data Package and Sample Size of Comparative Clinical Studies for Biosimilar Developments from PMDA Assessments

Published:2024-04-29 Issue:3 Volume:38 Page:225-239
ISSN:1178-2595
Container-title:Pharmaceutical Medicine
language:en
Short-container-title:Pharm Med

Author:

Kuribayashi Ryosuke^ORCID,Hariu Aya,Nakano Ayuki,Kishioka Yasuhiro

Publisher

Springer Science and Business Media LLC

Link

https://link.springer.com/content/pdf/10.1007/s40290-024-00525-y.pdf

Reference104 articles.

1. Ministry of Health, Labour and Welfare. Guideline for ensuring quality, safety, and efficacy of biosimilars. 2020. https://www.pmda.go.jp/files/000267479.pdf. Accessed 27 Mar 2024.

2. US FDA. Scientific considerations in demonstrating biosimilarity to a reference product. 2015. https://www.fda.gov/media/82647/download. Accessed 9 Oct 2023.

3. European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 2014. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-2.pdf. Accessed 9 Oct 2023.

4. Schiestl M, Ranganna G, Watson K, Jung B, Roth K, Capsius B, et al. The path towards a tailored clinical biosimilar development. BioDrugs. 2020;34(3):297–306. https://doi.org/10.1007/s40259-020-00422-1.

5. Cohen HP, Turner M, McCabe D, Woollett GR. Future evolution of biosimilar development by application of current science and available evidence: the developer’s perspective. BioDrugs. 2023;37(5):583–93. https://doi.org/10.1007/s40259-023-00619-0.