Erelzi Purple Book BLA 761042
- BLA number
- 761042
- Proprietary names
- Erelzi, Erelzi Sensoready
- Proper names
- etanercept-szzs
- Applicant
- Sandoz Inc.
- 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 | Erelzi | etanercept-szzs | 351(k) Biosimilar | 25MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | 2016-08-30 | |
| 002 | Erelzi | etanercept-szzs | 351(k) Biosimilar | 50MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | 2016-08-30 | |
| 003 | Erelzi Sensoready | etanercept-szzs | 351(k) Biosimilar | 50MG/ML | Injection | Subcutaneous | Autoinjector | Disc | Licensed | 2016-08-30 | |
| 004 | Erelzi | etanercept-szzs | 351(k) Biosimilar | 25MG | For Injection | Subcutaneous | Multi-Dose Vial | Disc | Licensed | 2022-11-10 | |
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 |
|---|
| 2023-01-01 | U | 001 | Erelzi | 351(k) Biosimilar | Disc | Sandoz Inc. |
| 2023-01-01 | U | 002 | Erelzi | 351(k) Biosimilar | Disc | Sandoz Inc. |
| 2023-01-01 | U | 003 | Erelzi Sensoready | 351(k) Biosimilar | Disc | Sandoz Inc. |
| 2023-01-01 | U | 004 | Erelzi | 351(k) Biosimilar | Disc | Sandoz Inc. |
| 2022-11-01 | N | 004 | Erelzi | 351(k) Biosimilar | Rx | Sandoz Inc. |
| 2022-07-01 | U | 001 | Erelzi | 351(k) Biosimilar | Rx | Sandoz Inc. |
| 2022-07-01 | U | 002 | Erelzi | 351(k) Biosimilar | Rx | Sandoz Inc. |
| 2022-07-01 | U | 003 | Erelzi Sensoready | 351(k) Biosimilar | Rx | Sandoz Inc. |
| 2022-06-01 | U | 001 | Erelzi | 351(k) Biosimilar | Disc | Sandoz Inc. |
| 2022-06-01 | U | 002 | Erelzi | 351(k) Biosimilar | Disc | Sandoz Inc. |
| 2022-06-01 | U | 003 | Erelzi Sensoready | 351(k) Biosimilar | Disc | Sandoz Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2023-01-01 | 001 | Erelzi | 351(k) Biosimilar | Disc | Licensed | 2016-08-30 |
| 2023-01-01 | 002 | Erelzi | 351(k) Biosimilar | Disc | Licensed | 2016-08-30 |
| 2023-01-01 | 003 | Erelzi Sensoready | 351(k) Biosimilar | Disc | Licensed | 2016-08-30 |
| 2023-01-01 | 004 | Erelzi | 351(k) Biosimilar | Disc | Licensed | 2022-11-10 |
| 2022-11-01 | 004 | Erelzi | 351(k) Biosimilar | Rx | Licensed | 2022-11-10 |
| 2022-07-01 | 001 | Erelzi | 351(k) Biosimilar | Rx | Licensed | 2016-08-30 |
| 2022-07-01 | 002 | Erelzi | 351(k) Biosimilar | Rx | Licensed | 2016-08-30 |
| 2022-07-01 | 003 | Erelzi Sensoready | 351(k) Biosimilar | Rx | Licensed | 2016-08-30 |
| 2022-06-01 | 001 | Erelzi | 351(k) Biosimilar | Disc | Licensed | 2016-08-30 |
| 2022-06-01 | 002 | Erelzi | 351(k) Biosimilar | Disc | Licensed | 2016-08-30 |
| 2022-06-01 | 003 | Erelzi Sensoready | 351(k) Biosimilar | Disc | Licensed | 2016-08-30 |
| 2020-05-01 | 001 | Erelzi | 351(k) Biosimilar | Rx | Licensed | 2016-08-30 |
| 2020-05-01 | 002 | Erelzi | 351(k) Biosimilar | Rx | Licensed | 2016-08-30 |
| 2020-05-01 | 003 | Erelzi Sensoready | 351(k) Biosimilar | Rx | Licensed | 2016-08-30 |
| 2020-02-01 | 001 | Erelzi | 351(k) Biosimilar | Marketed | Licensed | 2016-08-30 |
| 2020-02-01 | 002 | Erelzi | 351(k) Biosimilar | Marketed | Licensed | 2016-08-30 |
| 2020-02-01 | 003 | Erelzi | 351(k) Biosimilar | Marketed | Licensed | 2016-08-30 |