QL0902, a proposed etanercept biosimilar: pharmacokinetic and immunogenicity profile to its reference product in healthy Chinese male subjects

Abstract

ABSTRACT Objectives: To study the pharmacokinetics, safety and immunogenicity of Recombinant Human Tumor Necrosis Factor-α Receptor II: IgG Fc Fusion Protein for Injection (QL0902) and evaluate the pharmacokinetic similarity between QL0902 and reference Etanercept in healthy male subjects. Methods: A randomized, double-blinded, single-dose, two-period, two-sequence and crossover study was conducted in healthy males. Sixty-eight subjects were randomized at 1:1 ratio to receive a single 50-mg subcutaneous injection of QL0902 or reference Etanercept. The statistical analysis was conducted by SAS Enterprise Guide statistical software. Results: The main pharmacokinetic parameters of QL0902 were as follows: AUC0-∞ was 461861.60 ± 126861.42 (h*ng/mL), AUC0-t was 453304.68 ± 124424.94 (h*ng/mL), Cmax was (2634.03 ± 833.82)ng/mL; The main pharmacokinetic parameters of reference Etanercept were as follows: AUC0-∞ was 537977.72 ± 153295.70 (h*ng/mL), AUC0-t was 528817.19 ± 150910.05 (h*ng/mL), Cmax was (2874.21 ± 822.31) ng/mL. Conclusions: After a single subcutaneous injection of QL0902 and reference Etanercept, the 90% confidence intervals of the ratios of AUC0-∞, AUC0-t, Cmax of healthy subjects were respectively 82.76% to 89.15%, 82.66% to 89.00%, 87.30% to 93.95%, which were between 80.00% and 125.00%. It indicts that their pharmacokinetic characteristics were similar. No serious adverse events occurred and the immunogenicity of QL0902 was lower. Trial Registration: The trial is registered at www.chictr.org.cn (ChiCTR1900023 437).