Wezlana FDA Approval History

Last updated by Judith Stewart, BPharm on May 13, 2025.

FDA Approved: Yes (First approved October 31, 2023)
Brand name: Wezlana
Generic name: ustekinumab-auub
Dosage form: Injection
Company: Amgen Inc.
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis

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

• Wezlana is indicated for the treatment of adult patients with:
  - moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;
  - active psoriatic arthritis;
  - moderately to severely active Crohn’s disease; and
  - moderately to severely active ulcerative colitis.
  Wezlana is indicated for the treatment of pediatric patients 6 years of age and older with:
  - moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and
  - active psoriatic arthritis.
• Wezlana 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
  Autoinjector (Subcutaneous Injection)	45 mg / 0.5 mL	Biosimilar
  Autoinjector (Subcutaneous Injection)	90 mg / mL	Biosimilar
  Single-Dose Vial (Intravenous Injection)	130 mg / 26 mL (5 mg / mL)	Interchangeable

• Wezlana is administered by subcutaneous or intravenous injection.
• FDA approval of Wezlana was based on a comprehensive review of scientific evidence demonstrating that it is highly similar to Stelara and that there are no clinically meaningful differences between the two products in terms of safety, purity and potency. This evidence included comparisons of the products on an analytical level using tests and assays that confirmed similarity in the structural and functional features of Wezlana and Stelara, and comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data. The evidence also demonstrated that Wezlana met the other legal requirements to be interchangeable with Stelara at the pharmacy level.
• Warnings and precautions associated with Wezlana 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 include nasopharyngitis, upper respiratory tract infection, headache, fatigue, nausea, vomiting, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, sinusitis, abdominal pain, influenza, fever and diarrhea.
• Wezlana is the first FDA-approved Stelara biosimilar.

Stelara Biosimilars

Development timeline for Wezlana

Further information

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