Stelara Biosimilar Otulfi Approved by FDA to Treat Multiple Autoimmune Disorders

The FDA has approved Stelara biosimilar Otulfi (ustekinumab-aauz) to treat Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis, according to the details of a recent press release. Otulfi is set to launch in the United States or before Feb. 22, 2025. It will be available in subcutaneous and intravenous formulations for adults and children ages six and older. Approval was granted simultaneously in the European Union.

This approval is the result of a global commercialization partnership between biopharmaceutical companies Fresenius Kabi and Formycon.

“The U.S. approval is an important step on our path to sustainable profitability, since FYB202 will contribute strongly to the financial strength of Formycon,” Enno Spillner, chief financial officer of Formycon AG, said in a statement. “We are pleased that with the recent approval decisions of the European Commission and the FDA, we have now successfully completed the formal approval process of FYB202 for the major markets.”

Otulfi is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 responsible for the inflammation seen in autoimmune diseases.

Dosages for Otulfi are weight-based. Subcutaneous injections are available in 45 mg/0.5 mL or 90 mg/mL solutions in a single-dose prefilled syringe and intravenous infusions are available in 130 mg/26 mL (5 mg/mL) single-dose vials.

At least 3% of patients from each indication had one or more adverse reactions including:

• nasopharyngitis
• upper respiratory tract infection
• headache
• fatigue
• vomiting
• urinary tract infection
• injection site erythema
• vulvovaginal candidiasis
• bronchitis
• pruritus
• urinary tract infection
• sinusitis

Reference ustekinumab was originally approved by the FDA in 2009. Wezlana (ustekinumab-auub) was approved last October. Selarsdi (ustekinumab-aekn) was approved in April 2024 and Pyzchiva (ustekinumab-ttwe) was greenlit in June 2024.

Pricing information for Otulfi will be available closer to launch.