Immgolis Purple Book BLA 761452
- BLA number
- 761452
- Proprietary names
- Immgolis, Immgolis Intri
- Proper names
- golimumab-sldi
- Applicant
- Accord BioPharma Inc.
- Center
- CDER
- First observed release
- 2026-07-01
- Latest observed release
- 2026-07-01
- Newest archive release
- 2026-07-01
- 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 | Immgolis | golimumab-sldi | 351(k) Interchangeable | 50MG/0.5ML (100MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2026-05-15 | |
| 002 | Immgolis | golimumab-sldi | 351(k) Interchangeable | 100MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2026-05-15 | |
| 003 | Immgolis Intri | golimumab-sldi | 351(k) Interchangeable | 50MG/4ML (12.5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2026-05-15 | |
Reference Biological Product#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125289 | Simponi | golimumab | 351(a) | Rx | 2026-07-01 |
| 125433 | Simponi Aria | golimumab | 351(a) | Rx | 2026-07-01 |
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 |
|---|
| 2026-07-01 | N | 001 | Immgolis | 351(k) Interchangeable | Rx | Accord BioPharma Inc. |
| 2026-07-01 | N | 002 | Immgolis | 351(k) Interchangeable | Rx | Accord BioPharma Inc. |
| 2026-07-01 | N | 003 | Immgolis Intri | 351(k) Interchangeable | Rx | Accord BioPharma Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2026-07-01 | 001 | Immgolis | 351(k) Interchangeable | Rx | Licensed | 2026-05-15 |
| 2026-07-01 | 002 | Immgolis | 351(k) Interchangeable | Rx | Licensed | 2026-05-15 |
| 2026-07-01 | 003 | Immgolis Intri | 351(k) Interchangeable | Rx | Licensed | 2026-05-15 |