SAMSUNG BIOEPIS CO LTD — Pyzchiva FDA Summary Review (NDA/BLA 761373, 2025)
SAMSUNG BIOEPIS CO LTD · 2025 · FDA Summary Review (Drugs@FDA)
Report summary
The FDA approved Samsung Bioepis's Pyzchiva (ustekinumab-ttwe) autoinjector presentations (45 mg/0.5 mL and 90 mg/mL) as biosimilar to and interchangeable with US-Stelara prefilled syringes. This approval is notable as Stelara does not have an autoinjector presentation. The comprehensive review encompassed product quality, device assessment, and human factors studies, confirming that Pyzchiva met all necessary biosimilarity and interchangeability standards.
Key findings — cited to the page
| BSUFA Goal Date | January 29, 2025 | Pyzchiva (SB17) · p.1 |
| Approval date for Pyzchiva (SB17) PFS and IV vial as biosimilar | June 28, 2024 | Pyzchiva (SB17) · p.2 |
| Provisional determination date for Pyzchiva (SB17) PFS and IV vial as interchangeable | June 28, 2024 | Pyzchiva (SB17) · p.2 |
| Approval date for Pyzchiva (SB17) 45 mg/0.5 mL SC vial as biosimilar | December 20, 2024 | Pyzchiva (SB17) · p.2 |
| Provisional determination date for Pyzchiva (SB17) 45 mg/0.5 mL SC vial as interchangeable | December 20, 2024 | Pyzchiva (SB17) · p.2 |
| Approval date for interchangeable products (PFS and IV vial) | April 30, 2025 | Pyzchiva (SB17) · p.2 |
| Submission date for Prior Approval Supplement (PAS) 001 | July 29, 2024 | Pyzchiva (SB17) · p.3 |
| CUHF study submission date | October 15, 2024 | Pyzchiva (SB17) · p.4 |
| Goal date extension for CUHF study review | January 29, 2025 | · p.4 |
| Number of participants in CUHF study (45 mg dose) | 40 | Pyzchiva (SB17) · p.7 |
| Number of participants in CUHF study (90 mg dose) | 40 | Pyzchiva (SB17) · p.7 |
| PeRC review date | June 24, 2025 | · p.9 |
Source: SAMSUNG BIOEPIS CO LTD ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →