Bone metastases are secondary malignant tumors in bone caused by spread from a primary cancer elsewhere in the body. They are common in advanced malignancy and can cause pain, fractures, spinal cord compression, hypercalcemia, and major quality-of-life decline.
Biocon has launched denosumab biosimilars Bosaya and Aukelso in the United States following FDA approval with interchangeable designation. The products target osteoporosis and bone metastases, entering a market where denosumab products generated approximately $5 billion in U.S. sales in 2024. The launch represents a strategic expansion of Biocon's biosimilar portfolio amid competitive market conditions.
The global next generation drug conjugates market is projected to grow from $3.9 billion in 2026 to $10.9 billion by 2033 at 15.3% CAGR, while the radionuclide drug conjugate segment is forecast to reach $20.22 billion by 2032 at 9.6% CAGR.
The FDA approved multiple denosumab biosimilars in late 2025 and issued REMS safety updates emphasizing severe hypocalcemia risk in patients with advanced chronic kidney disease, including reported hospitalizations and fatalities.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07540650 |
Prophylactic Radiotherapy to Prevent Bone Complications in Patients With Metastatic Solid Cancers |
NOT_YET_RECRUITING | PHASE2 |
| NCT07537972 |
Denosumab Strategy for Liver Cancer With Bone Metastases |
NOT_YET_RECRUITING | PHASE2 |
| NCT07429422 |
SBRT Technique Implementation for Spinal Metastases Irradiation |
RECRUITING | NA |
| NCT07391410 |
Registry for Bone Metastases |
RECRUITING | |
| NCT07202273 |
Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases |
RECRUITING | NA |
| NCT07196995 |
Validation of Whole Body PET/CT Foundation Model |
NOT_YET_RECRUITING | |
| NCT07185958 |
Dual Energy CT - a Tool for Delineation of Tumor and Organs at Risk in Radiotherapy |
NOT_YET_RECRUITING | |
| NCT07146074 |
Early Radiotherapy Versus Observation for High-risk Asymptomatic or Minimally Symptomatic Bone Metastases |
RECRUITING | NA |
| NCT06918860 |
Analysis of Intramedullary Nail and Prosthetic Reconstruction After Surgical Treatment of Bone Metastases of Proximal Femur |
RECRUITING | |
| NCT06713941 |
Management of Bone Metastases |
ACTIVE_NOT_RECRUITING |
