Starjemza FDA Approval History

Last updated by Judith Stewart, BPharm on June 3, 2025.

FDA Approved: Yes (First approved May 22, 2025)
Brand name: Starjemza
Generic name: ustekinumab-hmny
Dosage form: Injection
Company: Bio-Thera Solutions, Ltd.
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis

Starjemza (ustekinumab-hmny) 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.

• Starjemza 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.
• Starjemza 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

• FDA approval was based on comprehensive analytical, non-clinical, and clinical data that demonstrated that Starjemza had similar efficacy, safety, immunogenicity, and quality as the reference product Stelara.
• Starjemza is administered by subcutaneous or intravenous injection.
• Warnings and precautions associated with Starjemza 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 (≥3%) include nasopharyngitis, upper respiratory tract infection, headache, and fatigue.
  - in Crohn’s Disease patients (≥3%) include vomiting (induction), and nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis (maintenance).
  - in ulcerative colitis patients (≥3%) include nasopharyngitis (induction), and nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea (maintenance).
• Starjemza is the eighth FDA-approved biosimilar to Stelara.

Stelara Biosimilars

Development timeline for Starjemza

Further information

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