Pharmacokinetics, safety, tolerability and immunogenicity of FKB327, a new biosimilar medicine of adalimumab/Humira, in healthy subjects

AIMS: To compare the pharmacokinetics, safety, tolerability and immunogenicity of FKB327, a biosimilar of adalimumab, with European Union (EU)‐approved Humira and US‐licensed Humira after single subcutaneous doses in healthy subjects. METHODS: In a randomized, double‐blind, parallel‐group study, 180...

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Publicado en:Br J Clin Pharmacol
Autores principales: Puri, Adeep, Niewiarowski, Andrew, Arai, Yasumasa, Nomura, Hideaki, Baird, Mark, Dalrymple, Isobel, Warrington, Steve, Boyce, Malcolm
Formato: Artigo
Lenguaje:Inglês
Publicado: John Wiley and Sons Inc. 2017
Materias:
Clinical Trials
Acceso en línea:https://ncbi.nlm.nih.gov/pmc/articles/PMC5465341/
https://ncbi.nlm.nih.gov/pubmed/28133772
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/bcp.13245
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