BLA 761452, held by Accord Biopharma Inc.. Golimumab-Sldi.
As of Nov 14, 2026, BLA 761452 (Immgolis, Immgolis Intri), held by Accord Biopharma Inc., was first approved by FDA on May 15, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 15, 2026 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Immgolis50MG/0.5ML · injection;solution | Golimumab-Sldi | Rx |
| Immgolis100MG/1ML · injection;solution | Golimumab-Sldi | Rx |
| Immgolis Intri50MG/4ML · injection;solution | Golimumab-Sldi | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
