Shots:
- The US FDA has granted interchangeable designation to Otulfi, a biosimilar version of Stelara (ustekinumab) to treat mod. to sev. active Crohn’s disease, ulcerative colitis, plaque PsO as well as active PsA, available in the US since March 2025
- 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 PsO pts
- Fresenius Kabi holds exclusive marketing rights of Otulfi in key global markets, with semi-exclusive rights in Germany plus parts of MENA & LATAM as per an agreement signed in Feb 2023 with Formycon
Ref: Businesswire| Image: Fresenius Kabi | Press Release
Related News:- Fresenius Kabi Launches Otulfi (Biosimilar, Stelara) in the US
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