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.
| Autor: | Wynne C; Biosimilar Trials, New Zealand Clinical Research, Christchurch, New Zealand., Schwabe C; Biosimilar Trials, New Zealand Clinical Research, Auckland, New Zealand., Stroissnig H; Clinical and Medical Affairs, Alvotech Germany GmbH, Jülich, Germany., Dias R; Clinical and Medical Affairs, Alvotech Swiss AG, Zürich, Switzerland., Sobierska J; Clinical and Medical Affairs, Alvotech Swiss AG, Zürich, Switzerland., Guenzi E; Preclinical Development and Project Management, UGA Biopharma GmbH, Hennigsdorf, Germany., Otto H; Clinical and Medical Affairs, Alvotech Germany GmbH, Jülich, Germany., Sattar A; Clinical and Medical Affairs, Alvotech UK Ltd, London, UK., Haliduola HN; Clinical and Medical Affairs, Alvotech Germany GmbH, Jülich, Germany., Edwald E; Combination Products & Devices, Alvotech Iceland, Reykjavik, Iceland., Berti F; Clinical and Medical Affairs, Alvotech Swiss AG, Zürich, Switzerland. |
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| Jazyk: | angličtina |
| Zdroj: | Expert opinion on biological therapy [Expert Opin Biol Ther] 2023 Jul-Dec; Vol. 23 (8), pp. 773-780. Date of Electronic Publication: 2022 Oct 05. |
| DOI: | 10.1080/14712598.2022.2131391 |
| Abstrakt: | Background: 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). Research Design and Methods: 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 Results: 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. Conclusion: 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. |
| Databáze: | MEDLINE |
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