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 (Cmax), area under the curve
(AUC) from time 0 extrapolated to infinity (AUC0-inf), and AUC from time 0 to 336 hours
(AUC0-336). 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 equivalence was demonstrated for
all primary PK endpoints. Geometric least squares means ratios (GMRs) for Cmax, AUC0-inf,
and AUC0-336were 99.4, 100.9, and 100.5, respectively, between the M923 and EU Humira
arms and 102.6, 104.2, and 102.9 between the M923 and US Humira arms. The 90% confidence
intervals of the GMRs for all PK endpoints were within prespecified confidence bounds
of 80%-125%. Adverse event rates were similar across the M923 (47.7%), US Humira (50.9%),
and EU Humira (53.3%) arms and were generally mild (73.7%) or moderate (22.0%). The
proportion of subjects with a confirmed antidrug antibody (ADA) response was similar
across study arms. This study demonstrated bioequivalent PK among M923, US Humira,
and EU Humira and demonstrated that the PK parameters were consistent with similar
safety and tolerability profile and ADA response rates.
Type
Journal articlePermalink
https://hdl.handle.net/10161/16151Published Version (Please cite this version)
10.1002/prp2.380Publication Info
Hillson, Jan; Mant, Tim; Rosano, Molly; Huntenburg, Carolyn; Alai-Safar, Mehrshid;
Darne, Siddhesh; ... Ganguly, Tanmoy (2018). Pharmacokinetic equivalence, comparable safety, and immunogenicity of an adalimumab
biosimilar product (M923) to Humira in healthy subjects. Pharmacol Res Perspect, 6(1). 10.1002/prp2.380. Retrieved from https://hdl.handle.net/10161/16151.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
Collections
More Info
Show full item recordScholars@Duke
Niti Goel
Adjunct Assistant Professor in the Department of Medicine

Articles written by Duke faculty are made available through the campus open access policy. For more information see: Duke Open Access Policy
Rights for Collection: Scholarly Articles
Works are deposited here by their authors, and represent their research and opinions, not that of Duke University. Some materials and descriptions may include offensive content. More info