TheraRadar
Data updated: May 26, 2026

DENOSUMAB-DSSB

Oncology Approved 2025-02-13
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
1
Years on Market

Details

Status
Prescription
First Approved
2025-02-13
Routes
SUBCUTANEOUS
Dosage Forms
INJECTABLE

Companies

SAMSUNG BIOEPIS CO LTD
Active Ingredient: DENOSUMAB-DSSB

DENOSUMAB-DSSB Approval History

2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2025 to 2025 · 1 indication expansions
Oct 2025 ORIGINAL
Efficacy
FDA Letter Label
Feb 2025 ORIGINAL
Update
FDA Letter Label

What DENOSUMAB-DSSB Treats

2 FDA approvals

Originally approved for its first indication in 2025 . Covers 2 distinct patient populations.

  • Other (2)
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

DENOSUMAB-DSSB FDA Label Details

Looking for the branded version?

OSPOMYV

Full clinical data, patents, trials, and competitive landscape for denosumab-dssb.

See OSPOMYV

Data Sources

FDA Approval: BLA761392 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.