Adalimumab is a monoclonal immunoglobulin G1-kappa isotype (IgG1-κ) antibody approved for the treatment of ankylosing spondylitis (AS).

In this multicenter, randomized, double-blind, parallel, positive control, phase III clinical trial carried out at 28 centers in China, patients with active AS received HS016 or adalimumab treatment. There were no differences between HS016 and adalimumab in terms of ASAS20 response rates, pharmacokinetic or immunogenic parameters, or treatment-emergent adverse events during the 24-week study period.

HS016 was similar to adalimumab in efficacy and safety. HS016 is a useful alternative to adalimumab for the treatment of AS.