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

Objectives: To study the pharmacokinetics, safety and immunogenicity of Recombinant Human Tumor Necrosis Factor-alpha 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: AUC(0-infinity) was 461861.60 +/- 126861.42 (h*ng/mL), AUC(0-t) was 453304.68 +/- 124424.94 (h*ng/mL), C-max was (2634.03 +/- 833.82)ng/mL; The main pharmacokinetic parameters of reference Etanercept were as follows: AUC(0-infinity) was 537977.72 +/- 153295.70 (h*ng/mL), AUC(0-t) was 528817.19 +/- 150910.05 (h*ng/mL), C-max 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 AUC(0-infinity), AUC(0-t), C-max 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.