Otulfi FDA Approval History

Last updated by Judith Stewart, BPharm on May 21, 2025.

FDA Approved: Yes (First approved September 27, 2024)
Brand name: Otulfi
Generic name: ustekinumab-aauz
Dosage form: Injection
Company: Fresenius Kabi USA, LLC
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis

Otulfi (ustekinumab-aauz) is a human interleukin-12 and -23 antagonist interchangeable biosimilar to Stelara used for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

• Otulfi is indicated for the treatment of:
  - moderate to severe plaque psoriasis in adults and pediatric patients 6 years and older who are candidates for phototherapy or systemic therapy.
  - active psoriatic arthritis (PsA) in adults and pediatric patients 6 years and older.
  - moderately to severely active Crohn's disease (CD) in adults.
  - moderately to severely active ulcerative colitis in adults.
• Otulfi is approved in the following presentations:
  

  Product Presentation	Strength	Biosimilar / Interchangeable
  Single-Dose Vial (Subcutaneous Injection)	45 mg / 0.5 mL	Interchangeable
  Pre-Filled Syringe (Subcutaneous Injection)	45 mg / 0.5 mL	Interchangeable
  Pre-Filled Syringe (Subcutaneous Injection)	90 mg / mL	Interchangeable
  Single-Dose Vial (Intravenous Injection)	130 mg / 26 mL (5 mg / mL)	Interchangeable

• Otulfi is administered by subcutaneous or intravenous injection.
• FDA approval of Otulfi was based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. Otulfi demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Stelara in patients with moderate to severe plaque psoriasis.
• Warnings and precautions associated with Otulfi include the increased risk of serious infections, an increased risk of malignancy, hypersensitivity reactions, Posterior Reversible Encephalopathy Syndrome (PRES), and an increased risk of noninfectious pneumonia.
• Common adverse reactions:
  - in psoriasis patients include nasopharyngitis, upper respiratory tract infection, headache, and fatigue.
  - in Crohn’s Disease patients include vomiting (induction), and nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis (maintenance).
  - in ulcerative colitis patients include nasopharyngitis (induction), and nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea (maintenance).
• Otulfi is the fourth FDA-approved Stelara biosimilar.

Stelara Biosimilars

Development timeline for Otulfi

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer