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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

Crossref DOI link: https://doi.org/10.1007/s40290-025-00583-w

Published Online: 2025-09-19

Published Print: 2025-11

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Goto, Kanoko

Hariu, Aya

Kuribayashi, Ryosuke https://orcid.org/0000-0002-6778-7114
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Text and Data Mining valid from 2025-09-19

Version of Record valid from 2025-09-19
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Article History

Accepted: 31 August 2025

First Online: 19 September 2025

Declarations

:

: K.G., A.H., and R.K. declare that they have no conflicts of interest relevant to the content of this article.

: Not applicable.

: Not applicable.

: Not applicable.

: Not applicable.

: G.K. was the primary writer of this article. G.K., A.H., and R.K. contributed to the fact-finding and editing of this article. All authors reviewed and approved the final version of the manuscript and agree to be accountable for the work.

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