Pharmaceutical giant Biocon has officially commenced the commercial launch of two biosimilars, Aukelso and Bosaya, in the United States. These products serve as alternatives to Amgen’s major brands, Xgeva and Prolia, marking a strategic milestone for the company in bone health management.
Key highlights of the launch include:
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Interchangeability and Substitution: Both Aukelso and Bosaya were granted “interchangeable” designations by the U.S. FDA in September 2025. This status allows for substitution at the pharmacy level without requiring additional provider intervention, in accordance with specific state laws.
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Presentation and Administration: Aukelso is available as a 120 mg/1.7 mL injection in a single-dose vial for subcutaneous use. Bosaya is offered in a 60 mg/mL concentration within a prefilled syringe, facilitating easier administration for patients and healthcare providers.
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Public Health Significance: Denosumab is a critical component in treating osteoporosis and cancer-related bone complications. In the U.S., approximately 10 million adults over age 50 suffer from osteoporosis, and over 330,000 cancer patients face bone metastases annually. The introduction of these biosimilars broadens access to high-quality, affordable treatment options.
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Strategic Vision: Shreehas Tambe, CEO and Managing Director of Biocon, emphasized that the introduction of Bosaya and Aukelso represents a strategic expansion of the company’s biosimilars portfolio, reinforcing its leadership in oncology and immunology following recent corporate integration.
The market entry of Aukelso and Bosaya is expected to increase competition in the U.S. bone health market—which generated $5 billion in sales in 2024—while providing more options for patients and the healthcare system.