A multicenter, randomized, open-label, 2-arm parallel study to compare the pharmacokinetics, safety and tolerability of AVT02 administered subcutaneously via prefilled syringe or autoinjector in healthy adults

• Published in: Expert opinion on biological therapy Vol. ahead-of-print; no. ahead-of-print; pp. 1 - 8
• Main Authors: Wynne, Christopher, Schwabe, Christian, Stroissnig, Heimo, Dias, Roshan, Sobierska, Joanna, Guenzi, Eric, Otto, Hendrik, Sattar, Abid, Haliduola, Halimu N, Edwald, Elin, Berti, Fausto
• Format: Journal Article
• Language: English
• Published: Taylor & Francis 03.08.2023
• Subjects: Adalimumab; autoinjector; AVT02; biosimilar; pharmacokinetics; prefilled syringe
• ISSN: 1471-2598; 1744-7682
• DOI: 10.1080/14712598.2022.2131391

AVT02 is an adalimumab biosimilar, with bioequivalence previously established along with clinical similarity. This study assessed the pharmacokinetic (PK) similarity of a single dose of 100 mg/mL AVT02 administered via prefilled syringe (PFS) or autoinjector (AI). In this open-label, 2-arm, parallel-group study, healthy adults were randomized 1:1 to receive one 40 mg (100 mg/mL) dose of AVT02 subcutaneously via PFS (N = 102) or AI (N = 105). Primary PK parameters (C max , AUC 0-t and AUC 0-inf ) were evaluated up to Day 64 of the study. Secondary PK parameters, safety, tolerability and immunogenicity were also assessed. The 90% CIs for the ratio of geometric least squares means were contained within the pre-specified 80-125% equivalence margins for the primary PK parameters, demonstrating bioequivalence of AVT02 when administered by PFS or AI. The incidence of treatment-emergent adverse events was comparable between the two groups, with a low frequency of injection site reactions observed. Immunogenicity profiles were also similar between the two groups. Bioequivalence was demonstrated for a single dose of AVT02 administered via PFS or AI. These results will help to increase availability of devices for patients, enabling treatment choice and flexibility.