Adapted from: Zhang et al. 2021.
†Actemra (US-sourced reference tocilizumab) and RoActemra (EU-sourced reference tocilizumab).
A randomized, double-blind, single-dose, 3-arm, parallel clinical study comparing the tolerance, immunogenicity, and pharmacokinetics of TOFIDENCE and EU- and US-sourced Actemra‡ in healthy volunteers.1
A Phase III study further evaluated the safety and efficacy of TOFIDENCE in a cohort of patients with RA.2
‡Actemra (US-sourced reference tocilizumab) and RoActemra (EU-sourced reference tocilizumab).
ADA=antidrug antibody; AE=adverse event; ANOVA=analysis of variance; AUC0-t=area under the curve from zero to the final quantifiable concentration; AUC0–∞=area under the curve from zero to infinity; CL=clearance; Cmax=maximum observable serum concentration; GMR=geometric mean ratio; IV=intravenous; PK=pharmacokinetic; SAE=serious adverse events; Tmax=the concentration-time data included time to peak; t1/2=half-life, Vz=volume of distribution.