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 and Fresenius Kabi | Image: Formycon and Fresenius Kabi | Press Release
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