Bio-Thera Solutions Ltd. has obtained NMPA approval for BAT-1806 to treat rheumatoid arthritis, systemic juvenile idiopathic arthritis and cytokine release syndrome. BAT-1806 is the world’s first tocilizumab biosimilar approved for marketing, according to Guangzhou, China-based Bio-Thera.
Four years after the EMA first approved Novartis AG's Ilaris (canakinumab) for the treatment of adult-onset Still’s disease (AOSD), the FDA has followed suit, giving it a green light in the indication following a priority review. The rare rheumatic condition usually affects younger adults and can occur as infrequently as once, but also intermittently or chronically.