Fresenius Kabi and Formycon Report the US FDA’s Approval of Otulfi (Biosimilar, Stelara)
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 supported by analytical, pre-clinical, clinical & manufacturing data that showed 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: Fresenius Kabi | Image: Fresenius Kabi & Formycon
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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.
