Biocon Launches Denosumab Biosimilars Bosaya and Aukelso in US Market
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.
Biocon Limited has commercially launched two denosumab biosimilars, Bosaya and Aukelso, in the United States following U.S. Food and Drug Administration approval with interchangeable designation in September 2025. The products are now available by prescription nationwide through specialty pharmacies and healthcare providers, targeting serious bone conditions including osteoporosis and bone metastases.
Bosaya is a biosimilar to Prolia, while Aukelso is a biosimilar to Xgeva. Both products were granted interchangeable designation by the FDA, allowing substitution at the pharmacy level in accordance with state laws. The company's CEO described the U.S. introduction as a strategic expansion of its biosimilars portfolio, building on established leadership in oncology and immunology.
Denosumab products play a critical role in bone health, treating osteoporosis and bone complications associated with cancer. In 2024, denosumab products generated approximately $5 billion in U.S. sales, reflecting the growing need for accessible treatment options. The launch could benefit an estimated 10 million adults with osteoporosis and over 330,000 patients annually with bone metastasis, a common complication of advanced cancer.
Bosaya is available as a 60 mg/mL injection for subcutaneous use in a prefilled syringe, while Aukelso is available as a 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial. Denosumab is a human monoclonal antibody that targets and binds to Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL), reducing bone breakdown and increasing bone mass and strength.
The company faces a competitive landscape in the biosimilar market, with the Denosumab biosimilar market anticipated to reach $1.5 billion by 2027. Biocon's own Denosumab biosimilars, Vevzuo and Evfraxy, have secured UK approval, positioning for entry into markets prioritizing cost-effectiveness. The company anticipates robust fiscal year 2027 growth fueled by upcoming launches of biosimilars including Aspart, Aflibercept, and Denosumab, alongside continued insulin demand.