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

Abstract Background FKB327 has been developed as a biosimilar of the adalimumab reference product (RP). We compared the pharmacokinetics (PK), safety, and immunogenicity of FKB327 with those of the adalimumab RP after a single dose by subcutaneous (SC) injection in Japanese male participants. Method...

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出版年:	BMC Pharmacology and Toxicology
主要な著者:	Takuma Yonemura, Rie Yazawa, Miwa Haranaka, Kazuki Kawakami, Masayuki Takanuma, Takumi Kanzo, Dimitris Stefanidis, Yasumasa Arai
フォーマット:	論文
言語:	英語
出版事項:	BMC 2022-01-01
主題:	Adalimumab Bioequivalence Biosimilar FKB327 Japanese Pharmacokinetics
オンライン･アクセス:	https://doi.org/10.1186/s40360-021-00545-3