FDA Approves Ustekinumab Biosimilar Otulfi

The US Food and Drug Administration has approved ustekinumab-aauz (Otulfi), a biosimilar that references Johnson & Johnson’s ustekinumab (Stelara).

This is the fourth ustekinumab biosimilar approved in the United States. Like the reference product, ustekinumab-aauz is indicated for:

• Patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;
• Patients 6 years or older with active psoriatic arthritis;
• Adult patients with moderately to severely active Crohn’s disease; and
• Adult patients with moderately to severely active ulcerative colitis.

Ustekinumab-aauz, produced by a partnership between Fresenius Kabi and Formycon, has two formulations: subcutaneous injection (45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe) or intravenous infusion (130 mg/26 mL solution in a single-dose vial).

The biosimilar will launch in the United States “no later than February 22, 2025,” according to the press release, “in accordance with the patent settlement between Fresenius Kabi, Formycon, and Johnson & Johnson.”

Ustekinumab-aauz is Fresenius Kabi’s fourth biosimilar granted US approval, behind adalimumab-aacf (Idacio), tocilizumab-aazg (Tyenne), and pegfilgrastim-fpgk (Stimufend).