Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Jul;83(7):1405-1415.
doi: 10.1111/bcp.13245. Epub 2017 Mar 9.

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

Adeep Puri  1 , Andrew Niewiarowski  1 , Yasumasa Arai  2 , Hideaki Nomura  2 , Mark Baird  3 , Isobel Dalrymple  3 , Steve Warrington  1 , Malcolm Boyce  1
Affiliations
Randomized Controlled Trial

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

Adeep Puri et al. Br J Clin Pharmacol. 2017 Jul.

Abstract

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 healthy subjects received by subcutaneous injection 40 mg of EU-Humira, or US-Humira, or FKB327, in a 1:1:1 ratio, stratified by bodyweight. Pharmacokinetics, local tolerability, immunogenicity, adverse events, vital signs, electrocardiography and laboratory safety tests were assessed prior to and up to 1536 h after treatment.

Results: The pharmacokinetics of FKB327 were similar to those of both EU- and US-Humira. The 90% confidence interval for the ratios of AUC0-t , AUC0-inf , and Cmax geometric means were in the acceptance range for bioequivalence of 0.80-1.25 for all three pairwise comparisons by analysis of covariance with baseline characteristics age, body weight and (for Cmax only) sex as covariates. Tolerability of all three treatments was equally acceptable, and there were no differences in safety profile or immunogenicity among the three treatments. Overall, antidrug antibodies were detected in approximately 70% of subjects who received each treatment; higher titres were associated with faster elimination of adalimumab.

Conclusions: The study demonstrated pharmacokinetic similarity of FKB327 with EU- and US-Humira. FKB327 was well tolerated by healthy subjects, with adverse effects similar to Humira. If clinical similarity to Humira, including efficacy, can be shown in patients, FKB327 will meet the criteria for biosimilarity to Humira.

Keywords: FKB327; Humira; TNF-α; adalimumab; biosimilar; monoclonal.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Linear (top) and semi‐log (bottom) mean serum concentration–time plots of adalimumab after a 40 mg dose for FKB327, EU‐Humira and US‐Humira
Figure 2
Figure 2
Mean serum concentration–time profiles of adalimumab by antidrug antibody activity in FKB327, EU‐Humira and US‐Humira treated subjects
See this image and copyright information in PMC

References

    1. Southan C, Sharman JL, Benson HE, Faccenda E, Pawson AJ, Alexander SP, et al. The IUPHAR/BPS guide to PHARMACOLOGY in 2016: towards curated quantitative interactions between 1300 protein targets and 6000 ligands. Nucleic Acids Res 2016; 44 (Database Issue): D1054–D1068. - PMC - PubMed
    1. Alexander SPH, Kelly E, Marrion N, Peters JA, Benson HE, Faccenda E, et al. The concise guide to PHARMACOLOGY 2015/16: Overview. Br J Pharmacol 2015; 172: 5729–5743. - PMC - PubMed
    1. Hussar DA. New drugs of 2003. J Am Pharm Assoc (2003) 2004; 44: 168–206 quiz 7‐10. - PubMed
    1. FDA . Prescribing information – HUMIRA (adalimumab) injection, for subcutaneous use. September 2015.
    1. EMA . Summary of product characteristics – Humira pre‐filled pen, pre‐filled syringe and vial. November 2015.

Publication types

MeSH terms