Formycon and Fresenius Kabi Reports the EC’s Approval of Otulfi (Biosimilar, Stelara) for Serious Inflammatory Diseases
Shots:
- The EC has approved Otulfi (IV/SC), a biosimilar of Stelara (ustekinumab), to treat mod. to sev. active CD, mod. to sev. plaque PsO & active PsA, valid across EU as well as Iceland, Liechtenstein & Norway
- Approval was based on analytical, pre-clinical, clinical & manufacturing data, depicting similar effectiveness, safety & PK profile of Otulfi vs Stelara in 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 | Image: Fresenius Kabi & Formycon
Related News:- Fresenius Kabi and Formycon Report the US FDA’s Approval of Otulfi (Biosimilar, Stelara)
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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.
