Biocon Limited has today announced the commercial launch of Bosaya™ (denosumab-kyqq) and Aukelso™ (denosumab-kyqq) in the United States.
Bosaya™ (biosimilar to Prolia®) and Aukelso™ (biosimilar to Xgeva®) are now available by prescription nationwide through specialty pharmacies and healthcare providers. Both products have been previously approved and granted an interchangeable designation by the U.S. Food and Drug Administration in September 2025, allowing substitution at the pharmacy level in accordance with state laws.
Shreehas Tambe, CEO & Managing Director, Biocon Limited, said, “The U.S. introduction of Bosaya™ and Aukelso™ marks a strategic expansion of our biosimilars portfolio, building on our established leadership in oncology and immunology. These therapies broaden access to high‑quality, affordable treatment options for patients living with serious bone conditions.”
Both biosimilars will be available in the most common presentations:
- Bosaya™ (biosimilar to Prolia®): 60 mg/mL injection for subcutaneous use in a prefilled syringe.
- Aukelso™ (biosimilar to Xgeva®): 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial.
Epidemiology:
Osteoporosis is a chronic disease that weakens bones, making them fragile and more prone to fracture. In the United States, approximately 10 million adults over age 50 are estimated to have osteoporosis, with another 44 million at risk due to low bone density.3,4 One in two women and up to one in four men over age 50 will break a bone in their lifetime due to osteoporosis.5
Bone metastases are a common complication of advanced cancer, affecting more than 330,000 patients annually in the United States.6 Skeletal complications can significantly impair quality of life and increase healthcare burden.7
Giant cell tumor of bone (GCTB) is a rare, locally aggressive benign tumor that primarily affects young adults. While noncancerous, it can cause severe pain, fractures, and disability.
Denosumab is a human monoclonal antibody that targets and binds to Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL). RANKL is essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. By blocking RANKL, denosumab reduces bone breakdown, increasing bone mass and strength.
