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Shots:
- Fresenius Kabi has launched Otulfi, an interchangeable biosimilar version of Stelara (ustekinumab), in a 45 mg/0.5 mL single-dose vial presentation for SC injection
- FDA approval was granted in Sep 2024 on the basis of analytical, pre-clinical, clinical & manufacturing data, showing similar efficacy, safety, PK & immunogenicity of Otulfi vs Stelara among mod. to sev. plaque psoriasis pts
- Otulfiis also available in 45mg/0.5mL & 90mg/mL single-dose PFS for SC injection & a 130mg/26mL single-dose vial for IV infusion, since Mar 2025
Ref: Businesswire | Image: Fresenius Kabi | Press Release
Related News: Fresenius Kabi’s Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva) Receives FDA’s Interchangeable Designation
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