By Fineline Cube 
Guangzhou-based Bio-Thera Solutions Ltd. (SHA: 688177) announced that it has received Biologic License Application (BLA) approval from the US Food and Drug Administration (FDA) for its BAT2206, a biosimilar of Johnson & Johnson’s (J&J) Stelara (ustekinumab). The approval allows the drug, marketed as Starjemza, to be used for treating adult patients with moderate to severe plaque psoriasis (PsO), active psoriatic arthritis (PsA), moderate to severe active Crohn’s disease (CD), and moderate to severe active ulcerative colitis (UC). It is also approved for pediatric patients with moderate to severe PsO and active PsA.
Stelara and Its Mechanism
Stelara is recognized as the world’s first all-human “dual-targeted” inhibitor of interleukin 12 (IL-12) and interleukin 23 (IL-23). This mechanism of action makes it effective in treating various autoimmune conditions. Bio-Thera’s biosimilar, Starjemza, is awaiting regulatory decisions in China and the European Union (EU).-Fineline Info & Tech