A pharmacokinetic (PK) similarity study between AVT05 and reference product golimumab

Introduction: AVT05, a recombinant human IgG1κ monoclonal antibody (mAb), is a proposed biosimilar to golimumab.

Objectives: This study assessed the pharmacokinetic (PK) similarity, safety, tolerability, and immunogenicity between AVT05 and reference product (RP) golimumab in healthy adult participants.

Methodology: 336 healthy male and female participants aged 18 to 55 years were randomized in a 1:1:1 ratio to AVT05, US licensed-RP (US-RP) or EU approved-RP (EU-RP; [Fig. 1]). 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 concentration-time curve from time zero to infinity (AUC_0-inf). PK similarity was demonstrated if the 90% confidence intervals (CIs) for the geometric mean ratio (GMR) for both AUC_0-inf and C_max were contained entirely within the prespecified margins of 80.00% and 125.00% for all six pairwise treatment comparisons ([Fig. 1]). Secondary endpoints were additional PK parameters, safety, tolerability and immunogenicity.

Fig. 1  

Results: Demographic and baseline characteristics were balanced between the treatment groups. The 90% CI for GMR of both primary PK parameters for all three pairwise comparisons was within the prespecified margins of 80.00% and 125.00% ([Fig. 2]). Secondary PK parameters were comparable among the treatment arms. Mean serum golimumab concentrations through Day 75 post-dose were similar between treatment arms.

Fig. 2  

The frequency of TEAEs was comparable among the treatment arms, and most were mild to moderate in severity. There were 2 serious TEAEs reported (1(0.9%) each in AVT05 and EU-RP arms), neither of which were considered treatment-related. Local administration site reactions were mild in severity and observed in 6.1%, 10.8% and 5.5% of participants in the AVT05, EU-RP and US-RP arms, respectively. Overall, 87 (75.7%), 92 (82.9%) and 89 (80.9%) participants in the AVT05, EU-RP and US-RP arms, respectively, were anti-drug antibodies (ADAs) positive, among those 66 (57.4%), 68 (61.3%) and 61 (55.5%) participants, respectively, were neutralizing antibodies (NAbs) positive at least once during the study.

Conclusion: Following a single dose administration, the study supported a demonstration of pharmacokinetic similarity between AVT05 and EU-and US-RP in healthy participants. Safety, tolerability, and immunogenicity profiles were comparable between the treatment arms.

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Publication History

Article published online:
04 September 2025