September 30, 2024
Formycon and Fresenius Kabi receive FDA approval for FYB202/ OtulfiTM
Formycon AG and its commercialization partner Fresenius Kabi jointly said Monday that the U.S. Food and Drug Administration (FDA) has approved FYB202/OtulfiTM1 (ustekinumab-aauz), a biosimilar to Stelara, for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis, the third Formycon biosimilar successfully approved by the FDA.