Imuldosa FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 15, 2024.

FDA Approved: Yes (First approved October 10, 2024)
Brand name: Imuldosa
Generic name: ustekinumab-srlf
Dosage form: Injection
Company: Dong-A ST
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis

Imuldosa (ustekinumab-srlf) 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.

• Imuldosa 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.
• Imuldosa is biosimilar to Stelara and does not have an interchangeability designation.
• FDA approval of Imuldosa was granted based on a comprehensive clinical development program. The data showed that Imuldosa is similar to its reference product Stelara in terms of pharmacokinetic characteristics, safety, tolerability, and efficacy, and that Imuldosa adheres to current biosimilar guidance from the FDA.
• Imuldosa is administered by subcutaneous or intravenous injection.
• Warnings and precautions associated with Imuldosa 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).
• Imuldosa is the fifth FDA-approved Stelara biosimilar, following the approvals of Otulfi (ustekinumab-aauz), Pyzchiva (ustekinumab-ttwe), and Selarsdi (ustekinumab-aekn) in 2024, and Wezlana (ustekinumab-auub) in 2023.

Development timeline for Imuldosa

Further information

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