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 36m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DENOSUMAB-DSSB is a monoclonal antibody (mAb) biosimilar approved February 2025 that blocks RANK Ligand to inhibit osteoclast formation and bone resorption. It is administered subcutaneously and is indicated for bone loss conditions managed by the reference denosumab product. The drug works by preventing the interaction between RANK Ligand and RANK, thereby reducing bone turnover and increasing bone mineral density.
Growth
Recent biosimilar launch entering growth phase; Samsung Bioepis team likely expanding commercial infrastructure to capture market share in established RANK Ligand inhibitor category.
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
Efficacy and Safety of Combination Denosumab With Eldecalcitol for Postmenopausal Women With Osteoporosis.(ESCORT)
Started Aug 2023
100 enrolled
Osteoporosis in Postmenopausal Women
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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.