EMERGE BIOSCIENCE PTE LTD: biosimilar supplement approved for YUSIMRY
EMERGE BIOSCIENCE PTE LTD: biosimilar supplement approved for YUSIMRY. Dated 40 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 | EMERGE BIOSCIENCE PTE LTD |
| Product | YUSIMRY |
| Generic / ingredient | ADALIMUMAB-AQVH |
| Approval | Other drug supplement |
| Application | BLA761216 supplement 11 |
| Decided | 2026-09-25 |
| Panel / class | INJECTABLE, INJECTION |
| Peer records CSV (500 records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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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: 2026-09-25
- 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 EMERGE BIOSCIENCE PTE LTD?
The FDA approved YUSIMRY (BLA761216 supplement 11) for EMERGE BIOSCIENCE PTE LTD on 2026-09-25: other drug supplement.
How does EMERGE BIOSCIENCE PTE LTD compare to other FdaApprovalPulse records?
It is 40 days old, still within a typical 45-day follow-up window. Its Score of 30/100 is modest; treat it as background rather than a priority.
EMERGE BIOSCIENCE PTE LTD vs. top 3 peers
| Organization | Record date |
|---|---|
| EMERGE BIOSCIENCE PTE LTD | 2026-09-25 |
| 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.