Application 761354
- Type
- BLA
- Sponsor
- BIOGEN MA
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761354 | Tofidence | tocilizumab-bavi | 351(k) Biosimilar | Rx | 2026-06-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TOFIDENCE | TOCILIZUMAB-BAVI | INJECTABLE;INJECTION | 80MG/4ML | No | No |
| 002 | TOFIDENCE | TOCILIZUMAB-BAVI | INJECTABLE;INJECTION | 200MG/10ML | No | No |
| 003 | TOFIDENCE | TOCILIZUMAB-BAVI | INJECTABLE;INJECTION | 400MG/20ML | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| TOFIDENCE | TOCILIZUMAB | Organon LLC | 1ab3207a-ebfe-4565-9ce5-3a1538815c83 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | BLA761354 |
| Tofidence | TOCILIZUMAB | Biogen MA Inc | 00529b23-850a-42b9-a152-125a95b5242c | 2025-12-19 | Boxed warning, Warnings, Adverse reactions | BLA761354 |