BLA 761350, held by Samsung Bioepis Co Ltd. Aflibercept-Yszy.
As of Nov 13, 2026, BLA 761350 (Opuviz), held by Samsung Bioepis Co Ltd, was first approved by FDA on May 20, 2024, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 20, 2024 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Opuviz2MG(0.05ML,40MG/ML) · injectable;injection | Aflibercept-Yszy | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 19, 2026 | Supplement 9Labeling · Standard review | Approved | |
| Aug 25, 2025 | Supplement 7Labeling · Standard review | Approved | |
| Jun 6, 2025 | Supplement 6Biosimilar | Approved | |
| May 20, 2024 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
