Pyzchiva FDA Approval History

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

FDA Approved: Yes (First approved June 28, 2024)
Brand name: Pyzchiva
Generic name: ustekinumab-ttwe
Dosage form: Injection
Company: Samsung Bioepis Co., Ltd.
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis

Pyzchiva (ustekinumab-ttwe) 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.

• Pyzchiva 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.
• Pyzchiva is approved 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

• Pyzchiva is administered by subcutaneous or intravenous injection.
• The FDA granted approval for Pyzchiva based on the totality of the evidence, including robust clinical studies confirming equivalent efficacy and comparable safety as Stelara.
• Warnings and precautions associated with Pyzchiva 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 include nasopharyngitis, upper respiratory tract infection, headache, fatigue, nausea, vomiting, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, sinusitis, abdominal pain, influenza, fever and diarrhea.
• Pyzchiva is the third FDA-approved Stelara biosimilar.

Stelara Biosimilars

Development timeline for Pyzchiva

Further information

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