# ELI LILLY AND CO: Biologic license for ONSWIK

**Score:** 55/100

| Field | Value |
|---|---|
| Sponsor | ELI LILLY AND CO |
| Product | ONSWIK |
| Generic / ingredient | INSULIN EFSITORA ALFA-GOBE |
| Approval | Biologic license (BLA) |
| Application | BLA761408 |
| Decided | 2026-09-23 |
| Panel / class | INJECTABLE, SUBCUTANEOUS |

## Why this score
- A new product launch.

Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761408). Last refreshed: 2026-11-03T05:14:00.980Z.
From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.