BLASUBCUTANEOUSINJECTABLE
Approved
Feb 2025
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
DENOSUMAB-DSSB (denosumab) by Samsung Bioepis is rank ligand blocking activity [moa]. First approved in 2025.
Drug data last refreshed 18h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DENOSUMAB-DSSB is a monoclonal antibody biosimilar that blocks RANK ligand to inhibit osteoclast formation and bone resorption. It is approved for conditions requiring bone loss prevention and management through subcutaneous injection. This Samsung Bioepis biosimilar entered the market on February 13, 2025, as a competitive alternative to the reference denosumab product.
Growth
Recent market entry as a biosimilar in growth phase creates opportunities for competitive positioning and market capture teams, though team expansion is likely dependent on uptake velocity.
Mechanism of Action
RANK Ligand Blocking Activity
Pharmacologic Class:
RANK Ligand Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Study on the Intervention Effect of Denosumab on High-Risk Patients With Osteoporotic Fractures in Type 2 Diabetes
Started Feb 2026
358 enrolled
Type 2 DiabetesOsteoporosisFractures
A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches
Started Jul 2025
12 enrolled
OsteoarthritisOsteoarthritis (OA) of the KneeOsteoporosis+2 more
Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease
Started Apr 2024
478 enrolled
Multiple MyelomaBone Diseases
Clinical Controlled Study on the Efficacy of Denosumab in Treating Osteoporosis in the Domestic Population and Its Impact on Sarcopenia-related Outcomes
Started Feb 2024
86 enrolled
SarcopeniaOsteoporosisDenosumab
Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)
Started Nov 2023
122 enrolled
Osteoporosis, Postmenopausal
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.