# TEVA PHARMACEUTICALS, INC.: biosimilar supplement approved for PONLIMSI

**Score:** 30/100

| Field | Value |
|---|---|
| Sponsor | TEVA PHARMACEUTICALS, INC. |
| Product | PONLIMSI |
| Generic / ingredient | DENOSUMAB-ADET |
| Approval | Other drug supplement |
| Application | BLA761385 supplement 6 |
| Decided | 2026-09-29 |
| Panel / class | INJECTABLE, SUBCUTANEOUS |

## Why this score


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=761385). Last refreshed: 2026-11-04T06:06:18.796Z.
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.