Opuviz Purple Book BLA 761350
- BLA number
- 761350
- Proprietary names
- Opuviz
- Proper names
- aflibercept-yszy
- Applicant
- Samsung Bioepis Co., Ltd.
- Center
- CDER
- First observed release
- 2024-05-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- No patents listed in the captured FDA patent list; source updated 2025-06-11
- Coverage
- Present in newest release
Latest Known Product Presentations#
Product, Proprietary name, Proper name table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | Opuviz | aflibercept-yszy | 351(k) Interchangeable | 2MG/0.05ML | Injection | Intravitreal | Single-Dose Vial | Rx | Licensed | 2024-05-20 | |
Reference Biological Product#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125387 | Eylea | aflibercept | 351(a) | Rx | 2026-06-01 |
Published Patent List#
No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2026-04-01 | U | 001 | Opuviz | 351(k) Interchangeable | Rx | Samsung Bioepis Co., Ltd. |
| 2024-05-01 | N | 001 | Opuviz | 351(k) Interchangeable | Rx | Samsung Bioepis Co., Ltd. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2024-05-01 | 001 | Opuviz | 351(k) Interchangeable | Rx | Licensed | 2024-05-20 |