Pharmacokinetic equivalence, comparable safety, and immunogenicity of an adalimumab biosimilar product (M923) to Humira in healthy subjects.

ABSTRACT: The aims of this randomized, double-blind, three-arm, single-dose study were to demonstrate pharmacokinetic (PK) equivalence of the adalimumab biosimilar M923 (hereafter referred to as "M923") to each of 2 reference products, and to assess M923's safety and immunogenicity. Primary PK endpoints were maximum observed concentration (C_max ), area under the curve (AUC) from time 0 extrapolated to infinity (AUC_0-inf ), and AUC from time 0 to 336 hours (AUC_0-336 ). Secondary endpoints included safety and immunogenicity assessments. Healthy subjects were randomized 1:1:1 to receive a 40-mg dose of M923 (n = 107); adalimumab US Humira (n = 105), hereafter referred to as "US Humira"; or adalimumab EU Humira (n = 103), hereafter referred to as "EU Humira." PK equivale

SUBMITTER: Hillson J 

PROVIDER: S-EPMC5817835 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature