Bio-Thera Reports the Regulatory Filing Acceptance for BAT2206 (Biosimilar, Stelara) Across the US and EU
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
Related News:- Bio-Thera Reports the Results for BAT2206 in P-III Trial for the Treatment of Plaque Psoriasis
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
