Biocon announced the commercial launch of Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq) in the United States. Bosaya, a biosimilar to Prolia, and Aukelso, a biosimilar to Xgeva, are available by prescription nationwide through specialty pharmacies and healthcare providers. Both products were previously approved and granted 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 and Managing Director, Biocon, 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. This milestone underscores Biocon’s strength as a portfolio development engine and our focus on building the world’s most scalable access platform—advancing life-changing medicines for patients and health systems across the United States and around the world.”
Denosumab products play a role in bone health, treating Osteoporosis and bone complications associated with cancer. In 2024, denosumab products generated approximately $5 billion in U.S. sales.
Bosaya is available as a 60 mg/mL injection for subcutaneous use in a prefilled syringe. Aukelso is available as a 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial.
Osteoporosis is a chronic disease that weakens bones, making them prone to fracture. In the United States, approximately 10 million adults over the age of 50 are estimated to have osteoporosis, with another 44 million at risk due to low bone density. One in two women and up to one in four men over the age of 50 will break a bone in their lifetime due to osteoporosis.
Bone metastases are a complication of advanced cancer, affecting more than 330,000 patients annually in the United States. Skeletal complications can impair quality of life and increase healthcare burden.
Giant Cell Tumor of Bone (GCTB) is a tumour that affects young adults. It can cause pain, fractures, and disability.