Yesintek FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 4, 2024.

FDA Approved: Yes (First approved November 29, 2024)
Brand name: Yesintek
Generic name: ustekinumab-kfce
Dosage form: Injection
Company: Biocon Biologics Ltd.
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis

Yesintek (ustekinumab-kfce) 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.

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

Development timeline for Yesintek

Further information

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