Shots:
- The US FDA has granted interchangeable designation to Selarsdi, a biosimilar version of Stelara (ustekinumab) for all indications incl. treatment of adult & pediatric PsA & plaque PsO as well as Crohn’s disease, & ulcerative colitis, effective as of Apr 30, 2025
- Selarsdi is an anti-IL-12/IL-23 mAb, with 4 approved presentations: 45mg/0.5mL & 90mg/mL prefilled SC syringes, 45mg/0.5mL single-dose vials for SC, & 130mg/26mL single-dose IV infusion vials
- Additionally, the US FDA has accepted BLAs for 3 Alvotech-Teva biosimilars: AVT05, a biosimilar version of Simponi & Simponi Aria (golimumab) & AVT06, a biosimilar version of Eylea (aflibercept), with BsUFA goal dates in Q4’25
Ref: Teva | Image: Teva and Alvotech
Related News:- Teva and Samsung Bioepis Launch Epysqli (Biosimilar, Soliris) in the US
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