Fresenius Kabi and Formycon Report the CHMP’s Positive Opinion of FYB202 (Biosimilar, Stelara)
Shots:
- The CHMP has granted 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: FORMYCON | Image: Fresenius Kabi & Formycon
Related News:- Formycon and Fresenius Kabi Settled with Johnson & Johnson for FYB202, a Proposed Biosimilar to Stelara (ustekinumab)
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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.
