GP2017-HCF, a high concentration formulation, demonstrates similar pharmacokinetics, immunogenicity and safety to GP2017, an approved adalimumab biosimilar

• Published in: Expert opinion on biological therapy Vol. ahead-of-print; no. ahead-of-print; pp. 1 - 10
• Main Authors: von Richter, Oliver, O'Reilly, Terry, Guerrieri, Davide, Fan, Jamie, Fey, Constanze, Schussler, Steven, Furlan, Fabricio, Lemke, Lena
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis 03.08.2023
• Subjects: Adalimumab; antidrug antibody; biosimilar; GP2017; high concentration formulation; immunogenicity; pharmacokinetics; PK comparability; antidrug antibody; PK comparability; high concentration formulation; pharmacokinetics; GP2017; Adalimumab; immunogenicity; biosimilar
• ISSN: 1471-2598; 1744-7682
• DOI: 10.1080/14712598.2022.2117546

GP2017 is an adalimumab biosimilar. The objective of this study is to compare the pharmacokinetics (PK) of GP2017 in its approved formulation and GP2017-high concentration formulation (HCF) in a randomized, double-blind, two-arm PK bridging study. Healthy male subjects received a single 40 mg subcutaneous injection of either GP2017-HCF (n = 162) or GP2017 (n = 168). PK, safety, and immunogenicity were assessed over 72 days post-injection. The 90% confidence intervals [CIs] of geometric mean ratios between GP2017-HCF and GP2017 for C max , AUC 0-inf , AUC 0-360 and AUC 0-last were within the pre-defined margin of 0.80 to 1.25; thus, PK comparability between GP2017-HCF and GP2017 was demonstrated. Subgroup analysis of PK comparability by anti-drug antibody (ADA) subpopulation showed that the 90% CIs of geometric mean ratios between GP2017-HCF and GP2017 for C max , AUC 0-inf , AUC 0-360 and AUC 0-last were within the margin of 0.80 to 1.25 in ADA-positive and ADA-negative subjects. The proportions of subjects with positive ADA responses and with neutralizing antibodies were comparable between the GP2017-HCF and GP2017 groups. GP2017-HCF and GP2017 were well tolerated, and there were no reports of deaths or other serious adverse events. Results show PK comparability between GP2017-HCF and GP2017 and comparable safety and tolerability.