Shots:
- The US FDA and EMA have accepted the BLA & MAA of BAT2206 for treating moderate to severe plaque PsO in adults eligible for phototherapy or systemic therapy, active PsA, moderate to severe active CD & moderate to severe active ulcerative colitis. BLA in China is under review
- The applications were supported by the data from P-I (US & EU) & P-III trials assessing equivalent efficacy, PK, safety & immunogenicity of BAT2206 vs Stelara among healthy subjects and patients with moderate to severe plaque PsO, respectively
- BAT2206, a biosimilar version of Stelara (ustekinumab), is a human mAb that prevents the binding of shared p40 with IL-12Rβ1 receptor protein to inhibit the activity of human IL-12 and IL-23
Ref: Bio-Thera | Image: Bio-Thera | Press Release
Related News:- Bio-Thera Solutions Reports the Initiation of Combined P-I/P-III Study of BAT3306 (Biosimilar, Keytruda)
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