Biocon announces commercial launch of Bosaya™ and Aukelso™, Denosumab Biosimilars in US

April 08, 2026 | Wednesday | News

Potential benefit to the estimated 10 million adults with osteoporosis and over 330,000 patients annually with bone metastasis

Bengaluru-based Biocon Limited has announced the commercial launch of Bosaya™ (denosumab-kyqq) and Aukelso™ (denosumab-kyqq) in the United States (US).

Bosaya™ (biosimilar to Prolia®) and Aukelso™ (biosimilar to Xgeva®) are now available by prescription nationwide through specialty pharmacies and healthcare providers.

Both products have been previously approved and granted interchangeable designation by the US Food and Drug Administration (FDA) in September 2025, allowing substitution at the pharmacy level in accordance with state laws.

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 US sales, reflecting the growing need for accessible treatment options.

Both biosimilars will be available in the most common presentations:

  • Bosaya™ (biosimilar to Prolia®): 60 mg/mL injection for subcutaneous use in a prefilled syringe.
  • Aukelso™ (biosimilar to Xgeva®): 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). RANKL is essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. By blocking RANKL, denosumab reduces bone breakdown, increasing bone mass and strength.

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