Treats moderate to severe plaque psoriasis. BLA 761373, held by Samsung Bioepis Co Ltd. Ustekinumab-Ttwe.
As of Nov 14, 2026, BLA 761373 (Pyzchiva), held by Samsung Bioepis Co Ltd, was first approved by FDA on Apr 30, 2025, with 5 approved supplements and 0 published complete response letters.
USTEKINUMAB-TTWE is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. active psoriatic arthritis (PsA). moderately to severely active Crohn's disease (CD). moderately to severely active ulcerative colitis. Pediatric patients 6 years and older with: moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy. active psoriatic arthritis (PsA). 1.
| Apr 30, 2025 | Original applicationNew active ingredient · Standard review | Approved | |
| Jun 28, 2024 | Original applicationNew active ingredient · Standard review | Approved |
| Pyzchiva45MG/0.5ML · injectable;injection | Ustekinumab-Ttwe | Rx |
| Pyzchiva90MG/ML · injectable;injection | Ustekinumab-Ttwe | Rx |
| Nov 18, 2025 | Supplement 6Labeling · Standard review | Approved | |
| Jun 27, 2025 | Supplement 1Manufacturing | Approved | |
| Apr 30, 2025 | Original applicationNew active ingredient · Standard review | Approved | |
| Apr 30, 2025 | Supplement 4 | Approved | |
| Mar 13, 2025 | Supplement 3Labeling · Standard review | Approved | |
| Dec 20, 2024 | Supplement 2Manufacturing | Approved | |
| Jun 28, 2024 | Original applicationNew active ingredient · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
