Shots:
- The CHMP has granted a positive opinion to Fresenius & Formycon’s FYB202, a biosimilar version of Stelara (ustekinumab), with the decision anticipated during Q4’24
- The opinion was supported by non-clinical & clinical studies plus manufacturing data, depicting similar effectiveness, safety & PK profile of FYB202 vs Stelara among moderate to severe psoriasis vulgaris (plaque psoriasis) patients
- FYB202, a human mAb, works by targeting cytokines interleukin-12 & interleukin-23. It is intended for serious inflammatory diseases in the areas of gastroenterology, dermatology & rheumatology
Ref: Fresenius Kabi and Formycon | Image: Fresenius Kabi and Formycon | Press Release
Related News:- Prestige Biopharma Reports the CHMP’s Positive Opinion of Tuznue (Biosimilar, Herceptin)
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