Biocon Launches Denosumab Biosimilars in U.S. Market

Biocon Limited has announced the commercial launch of its denosumab biosimilars, Bosaya™ and Aukelso™, in the United States. These products, biosimilars to Prolia® and Xgeva®, received U.S. FDA approval in September 2025 with an interchangeable designation. This allows for pharmacy-level substitution in accordance with state laws. The biosimilars are now available by prescription through specialty pharmacies and healthcare providers across the country.

Denosumab products play a significant role in treating osteoporosis and bone complications associated with cancer. In 2024, these products generated approximately $5 billion in U.S. sales. The launch of Bosaya™ and Aukelso™ aims to provide accessible treatment options for an estimated 10 million adults with osteoporosis and over 330,000 patients annually with bone metastasis, a common complication of advanced cancer.

The operational scope includes the availability of Bosaya™ as a 60 mg/mL injection for subcutaneous use in a prefilled syringe, and Aukelso™ as a 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial. These presentations are designed to meet the most common treatment needs for patients.

The U.S. FDA approval in September 2025 marked a significant milestone for Biocon, enabling the company to expand its biosimilars portfolio in the U.S. market. The launch follows the strategic timeline set by Biocon to enhance its presence in the global biopharmaceutical landscape.

Biocon Limited, an innovation-led global biopharmaceutical company, is responsible for the development and commercialization of these biosimilars. The company focuses on providing affordable, high-quality treatment options for serious bone conditions, reinforcing its leadership in oncology and immunology.

Denosumab biosimilars are critical in addressing the growing need for accessible treatment options in the U.S. market. The introduction of Bosaya™ and Aukelso™ is part of Biocon’s broader strategy to expand its biosimilars portfolio and provide scalable access to life-changing medicines for patients and health systems worldwide.

Biocon Limited is a global biopharmaceutical company focused on providing affordable medicines across chronic and non-communicable diseases. The company offers a diversified portfolio of biosimilars and generics, addressing high unmet needs in therapy areas such as diabetes, oncology, and bone health. Biocon has commercialized multiple biosimilar products and maintains a robust research and development pipeline, underscoring its commitment to sustainable growth and innovation.