Herzuma Purple Book BLA 761091
- BLA number
- 761091
- Proprietary names
- Herzuma
- Proper names
- trastuzumab-pkrb
- Applicant
- CELLTRION, 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 | Herzuma | trastuzumab-pkrb | 351(k) Biosimilar | 420MG | For Injection | Intravenous | Multi-Dose Vial | Rx | Licensed | 2018-12-14 | |
| 002 | Herzuma | trastuzumab-pkrb | 351(k) Biosimilar | 150MG | For injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2019-05-16 | |
Reference Biological Product#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 103792 | Herceptin | trastuzumab | 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 |
|---|
| 2021-07-01 | U | 001 | Herzuma | 351(k) Biosimilar | Rx | CELLTRION, Inc. |
| 2021-07-01 | U | 002 | Herzuma | 351(k) Biosimilar | Rx | CELLTRION, Inc. |
| 2021-05-01 | U | 001 | Herzuma | 351(k) Biosimilar | Rx | Celltrion |
| 2021-05-01 | U | 002 | Herzuma | 351(k) Biosimilar | Rx | Celltrion |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-05-01 | 001 | Herzuma | 351(k) Biosimilar | Rx | Licensed | 2018-12-14 |
| 2020-05-01 | 002 | Herzuma | 351(k) Biosimilar | Rx | Licensed | 2019-05-16 |
| 2020-02-01 | 001 | Herzuma | 351(k) Biosimilar | Marketed | Licensed | 2018-12-14 |
| 2020-02-01 | 002 | Herzuma | 351(k) Biosimilar | Marketed | Licensed | 2019-05-16 |