Fresenius Kabi, in collaboration with Formycon AG, announces that the ustekinumab biosimilar Otulfi (ustekinumab-aauz) developed by Formycon AG, is now available in the United States. Otulfi is an ustekinumab biosimilar for the reference product Stelara (ustekinumab). Otulfi is indicated for the treatment of moderately to severely active Crohn’s disease and ulcerative colitis in adult patients, moderate to severely active plaque psoriasis for adult patients and pediatric patients 6 years or older who are candidates for phototherapy or systemic therapy, and active psoriatic arthritis in adults and pediatric patients age 6 years or older. The drug received FDA approval in September 2024 and will be available in the US in the following presentations: a 45 mg/0.5 mL and 90 mg/mL single-dose prefilled syringe for injection and a 130 mg/26 mL (5 mg/mL) single dose vial for IV infusion.