Shots:
- The US FDA has approved Otulfi (SC & IV), biosimilar of Stelara (ustekinumab), to treat Crohn’s disease, ulcerative colitis, mod. to sev. plaque PsO & active psoriatic arthritis. Fresenius Kabi can market Otulfi by Feb 22, 2025
- Approval was based on analytical, pre-clinical, clinical & manufacturing data, showing similar efficacy, safety, PK & immunogenicity of Otulfi vs Stelara among mod. to sev. psoriasis vulgaris patients
- Additionally, Fresenius Kabi holds exclusive commercialization rights of Otulfi in key global markets, with semi-exclusive rights in Germany plus parts of MENA & LATAM. Formycon got upfront & is eligible for milestones, with both companies equally sharing post-commercialization value as per an agreement signed in Feb 2023
Ref: Formycon and Fresenius Kabi | Image: Formycon and Fresenius Kabi | Press Release
Related News:- Formycon and Fresenius Kabi Reports the EC’s Approval of Otulfi (Biosimilar, Stelara) for Serious Inflammatory Diseases
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