Also known as: Xgeva
Denosumab is a human monoclonal antibody targeting RANK ligand and is used for osteoporosis, treatment-induced bone loss, bone metastasis-related complications, and giant cell tumor of bone. It is marketed under brands including Prolia and Xgeva. The drug has U.S. approvals since 2010 and remains prescription-only.
Recent biosimilar and biologic developments included Health Canada approval of denosumab biosimilars, FDA review actions, and new licensing and commercialisation agreements. Other updates covered court, trial and reimbursement agenda decisions.
Alvotech said it will release first-quarter 2026 financial results on May 6, 2026, and host a webcast with live Q&A on May 7. The company said five biosimilars are already approved and marketed, with nine disclosed candidates in development.
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.
Recent studies examine self-management strategies for breast cancer treatment-related cardiotoxicity and highlight risks of vertebral fractures after discontinuing denosumab therapy in patients receiving aromatase inhibitors.
The FDA is expected to issue draft guidance reducing testing requirements for biosimilar drugs, potentially lowering development costs by USD 20 million. The move comes as the biosimilars market shows strong growth, with major launches in 2025.
Multiple pharmaceutical companies have initiated clinical trials for metastatic castration-resistant prostate cancer in February 2026, with over 180 companies developing 200+ pipeline therapies. Studies include combination therapies and novel drug candidates targeting advanced disease.
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 |
|---|---|---|---|
| NCT07537972 |
Denosumab Strategy for Liver Cancer With Bone Metastases |
NOT_YET_RECRUITING | PHASE2 |
| NCT07283887 |
Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis |
RECRUITING | PHASE4 |
| NCT07271771 |
The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity |
RECRUITING | PHASE4 |
| NCT06749886 |
An Exploratory Study of Tislelizumab in Combination with Chemotherapy in Immuno-experienced Patients with EGFR/ALK/ROS1-negative Advanced NSCLC in the Second-line Setting |
RECRUITING | PHASE2 |
| NCT06643780 |
RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis |
RECRUITING | PHASE4 |
| NCT06524960 |
Denosumab for Type 1 Diabetes |
RECRUITING | PHASE1/PHASE2 |
| NCT06472050 |
Romosozumab Versus Denosumab in Glucocorticoid-induced Osteoporosis: an Extended Observation of a Randomized Controlled Trial at 48 Months |
COMPLETED | PHASE4 |
| NCT06374459 |
Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis |
RECRUITING | PHASE1/PHASE2 |
| NCT06357741 |
Clinical Study of Desuzumab in the Treatment of Knee Osteoarthritis |
RECRUITING | |
| NCT06314698 |
Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease |
NOT_YET_RECRUITING | PHASE3 |
