The United States Food and Drug Administration has actually authorized ustekinumab-aauz (Otulfi), a biosimilar that recommendations Johnson & & Johnson’s ustekinumab (Stelara).
This is the 4th ustekinumab biosimilar authorized in the United States. Like the recommendation item, ustekinumab-aauz is shown for:
- Clients 6 years or older with moderate to serious plaque psoriasis who are prospects for phototherapy or systemic treatment;
- Clients 6 years or older with active psoriatic arthritis;
- Adult clients with reasonably to significantly active Crohn’s illness; and
- Adult clients with reasonably to badly active ulcerative colitis.
Ustekinumab-aauz, produced by a collaboration in between Fresenius Kabi and Formycon, has 2 solutions: subcutaneous injection (45 mg/0.5 mL or 90 mg/mL service in a single-dose prefilled syringe) or intravenous infusion (130 mg/26 mL option in a single-dose vial).
The biosimilar will introduce in the United States “no behind February 22, 2025,” according to journalism release, “in accordance with the patent settlement in between Fresenius Kabi, Formycon, and Johnson & & Johnson.”
Ustekinumab-aauz is Fresenius Kabi’s 4th biosimilar approved United States approval, behind adalimumab-aacf (Idacio), tocilizumab-aazg (Tyenne), and pegfilgrastim-fpgk (Stimufend).