Steqeyma FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 19, 2024.

FDA Approved: Yes (First approved December 17, 2024)
Brand name: Steqeyma
Generic name: ustekinumab-stba
Dosage form: Injection
Company: Celltrion USA
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis

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

• Steqeyma 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.
• Steqeyma is biosimilar to Stelara and does not have an interchangeability designation.
• FDA approval of Steqeyma was granted based on a clinical development program that demonstrated that Steqeyma was highly similar to its reference product Stelara.
• Steqeyma is administered by subcutaneous or intravenous injection.
• Warnings and precautions associated with Steqeyma 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).
• Steqeyma is the seventh FDA-approved Stelara biosimilar, following the approvals of Yesintek (ustekinumab-kfce), Imuldosa (ustekinumab-srlf), Otulfi (ustekinumab-aauz), Pyzchiva (ustekinumab-ttwe), and Selarsdi (ustekinumab-aekn) in 2024, and Wezlana (ustekinumab-auub) in 2023.

Development timeline for Steqeyma

Further information

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