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.
Blockbuster drugs worth hundreds of billions face generic competition as patents expire through 2032. Indian drugmakers could capture $3-5 billion of the opportunity, while GSK and Bristol Myers Squibb prepare for revenue losses.
The Senate HELP Committee advanced a bill to streamline biosimilar approvals by relying on analytical tests, potentially cutting development costs and time. The FDA has issued guidance removing comparative efficacy studies and is working to speed post-exclusivity approvals. Combined with administration support and PBM reforms, these moves aim to increase biosimilar competition and reduce drug prices.
NHMRC Tracker newsletters cover the new Research Translation Strategy 2026–2030, a revised generative AI policy, RRR Capacity Building grants, and consultations on drinking water and clinical guidelines.
Amgen shares have fallen 12.6% in three months despite relatively solid Q1 results, while Novo Nordisk maintains a 54.6% global GLP-1 market share. Both companies face pipeline competition and pricing pressures.
A Cleveland Clinic study found no racial survival disparities in multiple myeloma when patients have equal access to modern therapies. Clinical cases demonstrate long-term remission with second stem cell transplants and targeted agents like daratumumab.
European guidelines now recommend lutetium-177 PSMA-617 for advanced prostate cancer, while a machine-learning model predicts treatment radiation dose. A study finds DOACs safe with modern prostate cancer drugs.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07772609 |
Sequential Treatment With Romosozumab Followed by Denosumab vs. Zoledronic Acid for Gains in HIP BMD |
NOT_YET_RECRUITING | PHASE4 |
| NCT07757373 |
Romosozumab Versus Denosumab In Glucocorticoid-induced Osteoporosis: An Extended Observation Of a Clinical Trial at 6 Years |
NOT_YET_RECRUITING | PHASE4 |
| 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 |
