FDA Approval of JUBEREQ and OSVYRTI (denosumab-desu)

FDA Biosimilar Product Approvals

Published October 29th, 2025

Detected March 12th, 2026

Summary

The FDA has approved Biologic License Application (BLA) 761424 for JUBEREQ and OSVYRTI, both containing the active ingredient denosumab-desu, submitted by ACCORD BIOPHARMA INC. This approval marks the addition of new prescription injectable medications to the market.

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What changed

The U.S. Food and Drug Administration (FDA) has granted approval for Biologic License Application (BLA) 761424, submitted by ACCORD BIOPHARMA INC. The approved products are JUBEREQ and OSVYRTI, both utilizing denosumab-desu as the active ingredient, administered via subcutaneous injection in strengths of 120mg/1.7ml and 60mg/ml respectively. This approval signifies the successful completion of the FDA's review process for these new biologic drugs.

This approval is a significant event for ACCORD BIOPHARMA INC. and potentially for patients who may benefit from these new treatments. For drug manufacturers and pharmaceutical companies, this serves as an example of the regulatory pathway for new biologic approvals. No immediate compliance actions are required for other entities based solely on this approval notice, but it indicates a new product available for prescription and potential market entry.

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Biologic License Application (BLA): 761424
Company: ACCORD BIOPHARMA INC.
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Products on BLA 761424

| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
| --- | --- | --- | --- | --- | --- | --- | --- |
| JUBEREQ | denosumab-desu | 120MG/1.7ML | INJECTABLE;SUBCUTANEOUS | Prescription | None | No | No |
| OSVYRTI | denosumab-desu | 60MG/ML | INJECTABLE;SUBCUTANEOUS | Prescription | None | No | No |

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761424

Original Approvals or Tentative Approvals

| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 10/29/2025 | ORIG-1 | Approval | | N/A | Label (PDF)
Letter (PDF) | | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761424s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761424Orig1s000ltr.pdf |

Labels for BLA 761424

| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels,
Patient Package Insert | Note | Url |
| --- | --- | --- | --- | --- | --- |
| 10/29/2025 | ORIG-1 | Approval | Label (PDF) | | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761424s000lbl.pdf |