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November 10, 2025BioDrugsOpen Access

Pharmacokinetic Similarity of Biosimiliar AVT05 Versus Reference Product Golimumab in Healthy Adults: A Double-Blind, Three-Arm, Parallel-Group Study

Chris Wynne Ulrike Lorch Edrich Krantz Rohit Katial Thomas Ashdown Mónica Luque Abid Sattar Masna Rai Laxmikant Vashishta Katarina Petrovic Ruth Ruffieux Steffen Leutz Fausto Berti

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Key Points

Assess pharmacokinetic similarity between biosimilar AVT05 and reference product Golimumab in healthy adults.
Double-blind design
Three-arm parallel-group study
Healthy adult participants
Biosimilar AVT05 shows similar pharmacokinetic profile to Golimumab.
No significant differences in dosage absorption.

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Implication

Double-blind trial demonstrates pharmacokinetic similarity of biosimilar AVT05 to Golimumab in healthy adults, indicating effective alternatives.

Abstract

The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT05632211).

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Cite This Study

Wynne et al. (2025) studied this question.

synapsesocial.com/papers/69253a29c0ce034ddc357449 https://doi.org/10.1007/s40259-025-00749-7

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Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

1A pharmacokinetic (PK) similarity study between AVT05 and reference product golimumab2025
2Assessment of comparative efficacy between candidate biosimilar AVT05 and reference golimumab2025 · 1 citations
3Comparing the efficacy and safety of biosimilar BAT2506 with reference golimumab in patients with active psoriatic arthritis: 24-week results of a phase 3, multicenter, double-blind, randomized, parallel-group studyHuman Clinical Trial · 2026 · 1 citations
4Summary of Research: Effects of Adalimumab-adbm Versus Adalimumab Reference Product on Patient-Reported Outcomes in Rheumatoid Arthritis: Results from VOLTAIRE-RA2024
5Pharmacokinetic, Safety, and Immunogenicity Similarity of High‐ and Low‐Concentration Formulations of Adalimumab Biosimilar <scp>ABP</scp> 501, Adalimumab‐AttoOriginal Research · 2026

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Pharmacokinetic and safety analysis of biosimilar adalimumab in healthy volunteers in Bangladesh2024

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