TheraRadar
Data updated: May 26, 2026

PYZCHIVA (ustekinumab-ttwe)

Interleukin-12 Antagonists
Immunology Approved 2024-06-28

PYZCHIVA is indicated for the treatment of Plaque Psoriasis; Psoriatic Arthritis; Crohn's Disease; Ulcerative Colitis.

Source: FDA Label • SAMSUNG BIOEPIS CO LTD
2
Indications
--
Phase 3 Trials
1
Years on Market

Details

Status
Prescription
First Approved
2024-06-28
Routes
INJECTION, SUBCUTANEOUS
Dosage Forms
INJECTABLE

Companies

Active Ingredient: USTEKINUMAB-TTWE

PYZCHIVA Approval History

2025
2026
Original
New Indication
New Form
Label Update
20 FDA actions from 2024 to 2025
Nov 2025 SUPPL
Label · Labeling
Jun 2025 SUPPL
Mfg · Manufacturing (CMC)
Apr 2025 ORIGINAL
New Ingredient · Type 2 - New Active Ingredient

What PYZCHIVA Treats

4 indications

PYZCHIVA is approved for 4 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Plaque Psoriasis
  • Psoriatic Arthritis
  • Crohn's Disease
  • Ulcerative Colitis
Source: FDA Label
Auto-substitute OK for Stelara

Pharmacists can substitute PYZCHIVA for Stelara without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.

PYZCHIVA Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to PYZCHIVA

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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PYZCHIVA FDA Label Details

Indications & Usage

FDA Label (PDF)

PYZCHIVA is indicated for the treatment of Plaque Psoriasis; Psoriatic Arthritis; Crohn's Disease; Ulcerative Colitis.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.