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

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. METHODS: Two r...

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Detalles Bibliográficos
Autores principales: Yonemura, Takuma, Yazawa, Rie, Haranaka, Miwa, Kawakami, Kazuki, Takanuma, Masayuki, Kanzo, Takumi, Stefanidis, Dimitris, Arai, Yasumasa
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8742919/
https://www.ncbi.nlm.nih.gov/pubmed/34998419
http://dx.doi.org/10.1186/s40360-021-00545-3

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