Oziltus (denosumab-mobz)

Biosimilar

Region: 🇺🇸 US
Active substance: denosumab-mobz
Company: Amneal Pharms Llc
Status: Approved
FDA approval: Fri 19 Dec 2025
Designations: Biosimilar
Application: BLA761457
Official record: www.accessdata.fda.gov

Regulatory milestones

Fri 19 Dec 2025🇺🇸 FDA approval

FDA approves biosimilar Oziltus (denosumab-mobz)

Amneal Pharms Llc; BLA761457; Biosimilar; injectable · source

Same substance in other markets

🇺🇸 Boncresa Approved · Amneal Pharms Llc

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.