BILDYOS

🇺🇸 United States

FDA Page

Effective Date: Aug 18, 2026
Approval ID: b9e32bf7-d70a-4083-8577-c15751c7f769
Products: 0 registered
Version: 3

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use BILDYOS safely and effectively. See full prescribing information for BILDYOS. BILDYOS (denosumab-nxxp) injection, for subcutaneous use Initial U.S. Approval: 2025 BILDYOS (denosumab-nxxp) is biosimilar to PROLIA (denosumab)

Quick Stats

Total Products0

Labelers0

Label Sections0

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.