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

ABSTRACT:

Background

AVT05, a recombinant, human, immunoglobulin G1қ monoclonal antibody, is a biosimilar to Simponi^®.

Objectives

The purpose of this study was to investigate the pharmacokinetic (PK) similarity, safety, tolerability, and immunogenicity between AVT05 and US-licensed and European Union (EU)-approved reference product (RP) golimumab (US-RP and EU-RP, respectively) in healthy adult participants.

Methods

Three hundred and thirty-six healthy male and female participants aged 18-55 years were randomized in a 1:1:1 ratio to AVT05, US-RP, or EU-RP. Participants received a single 50 mg/0.5 mL subcutaneous injection on Day 1 and were followed until Day 75. The primary PK endpoints were maximum serum concentration (C_max) and area under the serum conce

SUBMITTER: Wynne C 

PROVIDER: S-EPMC12790511 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature