Eticovo Purple Book BLA 761066
- BLA number
- 761066
- Proprietary names
- Eticovo
- Proper names
- etanercept-ykro
- Applicant
- Samsung Bioepis Co., Ltd.
- Center
- CDER
- First observed release
- 2020-02-01
- 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 | Eticovo | etanercept-ykro | 351(k) Interchangeable | 50MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | 2019-04-25 | |
| 002 | Eticovo | etanercept-ykro | 351(k) Interchangeable | 25MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | 2019-04-25 | |
| 003 | Eticovo | etanercept-ykro | 351(k) Biosimilar | 50MG/ML | Injection | Subcutaneous | Autoinjector | Disc | Licensed | 2024-05-03 | |
Reference Biological Product#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 103795 | Enbrel | etanercept | 351(a) | Disc | 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 |
|---|
| 2026-05-01 | U | 001 | Eticovo | 351(k) Interchangeable | Disc | Samsung Bioepis Co., Ltd. |
| 2026-05-01 | U | 002 | Eticovo | 351(k) Interchangeable | Disc | Samsung Bioepis Co., Ltd. |
| 2024-07-01 | U | 001 | Eticovo | 351(k) Interchangeable | Disc | Samsung Bioepis Co., Ltd. |
| 2024-07-01 | U | 002 | Eticovo | 351(k) Interchangeable | Disc | Samsung Bioepis Co., Ltd. |
| 2024-05-01 | N | 003 | Eticovo | 351(k) Biosimilar | Disc | Samsung Bioepis Co., Ltd. |
| 2021-10-01 | U | 002 | Eticovo | 351(k) Biosimilar | Disc | Samsung Bioepis Co., Ltd. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2024-07-01 | 001 | Eticovo | 351(k) Interchangeable | Disc | Licensed | 2019-04-25 |
| 2024-07-01 | 002 | Eticovo | 351(k) Interchangeable | Disc | Licensed | 2019-04-25 |
| 2024-05-01 | 003 | Eticovo | 351(k) Biosimilar | Disc | Licensed | 2024-05-03 |
| 2021-10-01 | 001 | Eticovo | 351(k) Biosimilar | Disc | Licensed | 2019-04-25 |
| 2021-10-01 | 002 | Eticovo | 351(k) Biosimilar | Disc | Licensed | 2019-04-25 |
| 2020-05-01 | 001 | Eticovo | 351(k) Biosimilar | Rx | Licensed | 2019-04-25 |
| 2020-05-01 | 002 | Eticovo | 351(k) Biosimilar | Rx | Licensed | 2019-04-25 |
| 2020-02-01 | 001 | Eticovo | 351(k) Biosimilar | Marketed | Licensed | 2019-04-25 |
| 2020-02-01 | 002 | Eticovo | 351(k) Biosimilar | Marketed | Licensed | 2019-04-25 |