SAMSUNG BIOEPIS CO LTD: bioequivalence supplement approved for EPYSQLI
SAMSUNG BIOEPIS CO LTD: bioequivalence supplement approved for EPYSQLI. Dated 128 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 7 published fields of this record are shown below. Locked: 499 related FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | SAMSUNG BIOEPIS CO LTD |
| Product | EPYSQLI |
| Generic / ingredient | ECULIZUMAB-AAGH |
| Approval | Other drug supplement |
| Application | BLA761340 supplement 24 |
| Decided | 2026-06-29 |
| Panel / class | INJECTION, SOLUTION |
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CSV columns: Sponsor · Product · Approval · Decided · official source URL
- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-06-29
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
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30 / 100 Score
What is the FdaApprovalPulse record for SAMSUNG BIOEPIS CO LTD?
The FDA approved EPYSQLI (BLA761340 supplement 24) for SAMSUNG BIOEPIS CO LTD on 2026-06-29: other drug supplement.
How does SAMSUNG BIOEPIS CO LTD compare to other FdaApprovalPulse records?
It is 128 days old; check the official source for later updates before acting. Its Score of 30/100 is modest; treat it as background rather than a priority.
SAMSUNG BIOEPIS CO LTD vs. top 3 peers
| Organization | Record date |
|---|---|
| SAMSUNG BIOEPIS CO LTD | 2026-06-29 |
| AMGEN INC | 2026-09-29 |
| TEVA PHARMACEUTICALS, INC. | 2026-09-29 |
| CELLTRION INC | 2026-09-29 |
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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.