Selarsdi FDA Approval History

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

FDA Approved: Yes (First approved April 16, 2024)
Brand name: Selarsdi
Generic name: ustekinumab-aekn
Dosage form: Injection
Company: Alvotech and Teva Pharmaceuticals
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis

Selarsdi (ustekinumab-aekn) 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.

• Selarsdi 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.
  Selarsdi 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.
• Selarsdi is available 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

• Selarsdi is administered by subcutaneous or intravenous injection.
• FDA approval of Selarsdi was based on data from the AVT04-GL-301 and AVT04-GL-101 clinical studies comparing Selarsdi to the reference product Stelara. Results demonstrated that Selarsdi was highly similar to Stelara with no clinically meaningful differences in terms of safety, tolerability, and immunogenicity.
• Warnings and precautions associated with Selarsdi include an 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).
• Selarsdi is the second FDA-approved Stelara biosimilar.

Stelara Biosimilars

Development timeline for Selarsdi

Further information

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