Biocon Limited, a global biopharmaceutical company, has announced the commercial launch of its denosumab biosimilars, Bosaya™ and Aukelso™, in the United States. These products, which are biosimilars to Prolia® and Xgeva® respectively, are now available through specialty pharmacies and healthcare providers nationwide. Both Bosaya™ and Aukelso™ received approval and an interchangeable designation from the U.S. Food and Drug Administration in September 2025, allowing for pharmacy-level substitution in accordance with state laws.
Shreehas Tambe, CEO & Managing Director of Biocon Limited, highlighted the strategic significance of this launch, stating that it marks an expansion of Biocon’s biosimilars portfolio, reinforcing its leadership in oncology and immunology. He emphasised that these therapies will broaden access to affordable treatment options for patients with serious bone conditions, showcasing Biocon’s commitment to advancing life-changing medicines globally.
Denosumab products are crucial in managing bone health, particularly for treating osteoporosis and bone complications related to cancer. In 2024, these products generated approximately $5 billion in U.S. sales, indicating a strong demand for accessible treatment options.
Bosaya™ is available as a 60 mg/mL injection for subcutaneous use in a prefilled syringe, while Aukelso™ is offered as a 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial.
Osteoporosis, a chronic disease that weakens bones, affects an estimated 10 million adults over age 50 in the United States, with another 44 million at risk due to low bone density. Additionally, bone metastases, a common complication of advanced cancer, impact over 330,000 patients annually in the U.S., significantly affecting their quality of life and increasing healthcare burdens.
Denosumab, the active ingredient in both Bosaya™ and Aukelso™, is a human monoclonal antibody that targets RANKL, a protein essential for osteoclast function, thereby reducing bone breakdown and increasing bone mass and strength.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).