Alymsys Purple Book BLA 761231
- BLA number
- 761231
- Proprietary names
- Alymsys
- Proper names
- bevacizumab-maly
- Applicant
- Amneal Pharmaceuticals LLC
- Center
- CDER
- First observed release
- 2022-04-01
- 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 | Alymsys | bevacizumab-maly | 351(k) Biosimilar | 100MG/4ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2022-04-13 | |
| 002 | Alymsys | bevacizumab-maly | 351(k) Biosimilar | 400MG/16ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2022-04-13 | |
Reference Biological Product#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125085 | Avastin | bevacizumab | 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 |
|---|
| 2022-04-01 | N | 001 | Alymsys | 351(k) Biosimilar | Rx | Amneal Pharmaceuticals LLC |
| 2022-04-01 | N | 002 | Alymsys | 351(k) Biosimilar | Rx | Amneal Pharmaceuticals LLC |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2022-04-01 | 001 | Alymsys | 351(k) Biosimilar | Rx | Licensed | 2022-04-13 |
| 2022-04-01 | 002 | Alymsys | 351(k) Biosimilar | Rx | Licensed | 2022-04-13 |