Pharmaceuticals
USFDA7 April 2026 at 10:37 am

Biocon Launches Bosaya™ and Aukelso™, Denosumab Biosimilars in U.S.

AI Summary

Biocon Limited, an innovation-led global biopharmaceutical company, announced the commercial launch of Bosaya™ and Aukelso™, denosumab biosimilars, in the United States. Bosaya™ is a biosimilar to Prolia® and Aukelso™ is a biosimilar to Xgeva®, both approved by the U.S. Food and Drug Administration in September 2025 with an interchangeable designation. These therapies are now available by prescription nationwide through specialty pharmacies and healthcare providers. 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. Both biosimilars will be available in the most common presentations.

Key Highlights

  • Biocon announces U.S. commercial launch of Bosaya™ and Aukelso™, denosumab biosimilars.
  • Both products have been approved and granted interchangeable designation by the U.S. FDA in September 2025.
  • Potential benefit to the estimated 10 million adults with osteoporosis and over 330,000 patients annually with bone metastasis.
  • Denosumab products play a critical role in bone health, treating osteoporosis and bone complications associated with cancer.
  • Both biosimilars will be available in the most common presentations.