Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014


Planegg-Martinsried, Germany, September 27, 2024 – Formycon AG (FSE: FYB, “Formycon“) announces that the U.S. Food and Drug Administration (“FDA”) today approved FYB202/OtulfiTM1 (ustekinumab-aauz), a biosimilar to Stelara®2.

FYB202/OtulfiTM obtained FDA approval for the treatment of patients with Crohn’s disease, ulcerative colitis, moderate-to-severe plaque psoriasis and active psoriatic arthritis.

The approval for FYB202/OtulfiTM is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202/OtulfiTM demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).
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1) OtulfiTM is a Trademark of Fresenius Kabi Deutschland GmbH in selected countries
2) Stelara® is a registered Trademark of Johnson & Johnson