Yusimry Purple Book BLA 761216
- BLA number
- 761216
- Proprietary names
- Yusimry
- Proper names
- adalimumab-aqvh
- Applicant
- Hong Kong King-Friend Industrial Company Limited
- Center
- CDER
- First observed release
- 2021-12-01
- 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 | Yusimry | adalimumab-aqvh | 351(k) Biosimilar | 40MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2021-12-17 | |
| 002 | Yusimry | adalimumab-aqvh | 351(k) Biosimilar | 40MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2023-02-27 | |
Reference Biological Product#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125057 | Humira | adalimumab | 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 |
|---|
| 2024-10-01 | U | 001 | Yusimry | 351(k) Biosimilar | Rx | Hong Kong King-Friend Industrial Company Limited |
| 2024-10-01 | U | 002 | Yusimry | 351(k) Biosimilar | Rx | Hong Kong King-Friend Industrial Company Limited |
| 2023-03-01 | N | 002 | Yusimry | 351(k) Biosimilar | Rx | Coherus BioSciences, Inc. |
| 2021-12-01 | N | 001 | Yusimry | 351(k) Biosimilar | Rx | Coherus BioSciences, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2023-03-01 | 002 | Yusimry | 351(k) Biosimilar | Rx | Licensed | 2023-02-27 |
| 2021-12-01 | 001 | Yusimry | 351(k) Biosimilar | Rx | Licensed | 2021-12-17 |