On 18 January 2024, a phase 3 study, published in The Lancet Rheumatology, sponsored by Bio-Thera and Biogen concluded that BAT1806 (tocilizumab biosimilar) was equivalent in efficacy, safety, immunogenicity, and pharmacokinetic in comparison to Roche’s RoActemra®(tocilizumab). The study was randomized, double-blinded, multicenter, and multinational. It consisted of a 24-week initial treatment period (TP1), a 24-week secondary treatment period (TP2), and an extra 4-week follow-up period. In total there were 621 participants out of which 309 were assigned to the reference tocilizumab group and the rest 312 were assigned to the BAT1806 group.
On 16 January 2023, Bio-Thera Solutions announced that China’s NMPA approved its BAT1806 for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome.