Biocon Launches Bosaya™ and Aukelso™ Denosumab Biosimilars in U.S.
Biocon Limited launched Bosaya™ and Aukelso™, denosumab biosimilars, in the U.S. following FDA approval in September 2025. These biosimilars offer affordable treatment options for osteoporosis and bone metastases. Denosumab products generated $5 billion in U.S. sales in 2024.
The launch of biosimilars in the U.S. market, which has significant sales for denosumab products, is expected to have a notable impact on Biocon's revenue and market presence in the biopharmaceutical sector.
The launch of new biosimilar products in a major market like the U.S. is a positive development for the company, expanding its portfolio and market reach.
Biocon Limited has announced the commercial launch of its denosumab biosimilars, Bosaya™ and Aukelso™, in the United States. These products, previously approved with an interchangeable designation by the U.S. FDA in September 2025, are now available nationwide through specialty pharmacies and healthcare providers.
Bosaya™ is a biosimilar to Prolia® and Aukelso™ is a biosimilar to Xgeva®, both targeting osteoporosis and bone complications associated with cancer. The U.S. introduction represents a strategic expansion of Biocon's biosimilars portfolio, aiming to broaden access to affordable treatment options for an estimated 10 million adults with osteoporosis and over 330,000 patients annually with bone metastasis.
Denosumab products generated approximately $5 billion in U.S. sales in 2024. Biocon's CEO & Managing Director, Shreehas Tambe, highlighted the milestone as underscoring Biocon's strength in portfolio development and its focus on building a scalable access platform for life-changing medicines.
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