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Comparison of two biosimilarity studies of FKB327 with the adalimumab reference product: randomized phase 1 studies of single-blind, single-dose subcutaneous injection in healthy Japanese male participants

Crossref DOI link: https://doi.org/10.1186/s40360-021-00545-3

Published Online: 2022-01-08

Published Print: 2022-12

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

Authors

Yonemura, Takuma

Yazawa, Rie

Haranaka, Miwa

Kawakami, Kazuki

Takanuma, Masayuki

Kanzo, Takumi

Stefanidis, Dimitris

Arai, Yasumasa http://orcid.org/0000-0002-1316-574X
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Article History

Received: 5 March 2021

Accepted: 17 December 2021

First Online: 8 January 2022

Declarations

:

: Both FKB327–004 and − 006 studies were approved by the Hakata Clinic Institutional Review Board, Fukuoka, Japan under the committee’s reference numbers: 1570BS (18/12/2015) and 1570BS-2 (16/06/2017), respectively, and the studies were conducted in compliance with the International Ethical Guidelines for Biomedical Research Involving Human Subjects, International Conference on Harmonisation Good Clinical Practice (ICH-GCP) guidelines, the Declaration of Helsinki, and local laws. All participants provided written informed consent prior to initiation of the study, in accordance with ICH-GCP.

: Not applicable.

: Takuma Yonemura, Rie Yazawa, and Miwa Haranaka received a research grant from Fujifilm Kyowa Kirin Biologics Co. Ltd. to conduct the FKB327–004 study. Kazuki Kawakami, Masayuki Takanuma, and Yasumasa Arai are employees of Fujifilm Kyowa Kirin Biologics Co. Ltd. Takumi Kanzo is an employee of Mylan EPD G.K. Dimitris Stefanidis is an employee of Viatris Inc. (formerly Mylan Inc.).

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