Selarsdi FDA Approval History
Last updated by Judith Stewart, BPharm on April 17, 2024.
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
Selarsdi (ustekinumab-aekn) is a human interleukin-12 and -23 antagonist biosimilar to Stelara used for the treatment of plaque psoriasis and psoriatic arthritis.
- Selarsdi is indicated for the treatment of adult patients and pediatric patients 6 years and older with:
- moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy.
- active psoriatic arthritis (PsA).
Unlike Stelara, Selarsdi is not indicated for use in the treatment of adults with Crohn’s disease or ulcerative colitis, and is not available as an injectable formulation for intravenous infusion. - Selarsdi is biosimilar to Stelara and does not have an interchangeability designation.
- Selarsdi is administered by subcutaneous 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 include nasopharyngitis, upper respiratory tract infection, headache, and fatigue.
- Selarsdi is the second FDA-approved Stelara biosimilar, following the approval of Wezlana (ustekinumab-auub) in 2023.
Development timeline for Selarsdi
Further information
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