Biocon Launches Denosumab Biosimilars in US, Expands Footprint in Bone Health Market
Chief Executive Officer and Managing Director of Biocon, Shreehas Tambe said the launch represents a strategic milestone in strengthening the company’s presence in oncology and immunology, while expanding access to high-quality therapies.
Bosaya and Aukelso target osteoporosis and cancer-related bone complications, addressing large patient base
Bengaluru/New Jersey: India’s biopharmaceutical major Bocon Limited on Tuesday announced the commercial launch of its denosumab biosimilars – Bosaya and Aukelso – in the United States, marking a significant expansion of its biosimilars portfolio in the global healthcare market.
The two products, approved by the US Food and Drug Administration in September 2025 with interchangeable designation, are now available nationwide through specialty pharmacies and healthcare providers.
Bosaya is a biosimilar to Prolia, used in the treatment of osteoporosis, while Aukelso is a biosimilar to Xgeva, indicated for preventing bone complications in cancer patients. The launch is expected to improve access to affordable treatment options for an estimated 10 million adults with osteoporosis and over 330,000 patients affected annually by bone metastasis in the US.
Chief Executive Officer and Managing Director of Biocon, Shreehas Tambe said the launch represents a strategic milestone in strengthening the company’s presence in oncology and immunology, while expanding access to high-quality therapies.
Denosumab-based therapies play a critical role in bone health by targeting RANKL, a protein involved in bone resorption. By inhibiting this pathway, the drugs help increase bone density and reduce the risk of fractures and skeletal complications.
The U.S. market for denosumab products is significant, with annual sales estimated at around $5 billion, reflecting strong demand for treatments addressing osteoporosis and cancer-related bone conditions.
Both biosimilars will be available in standard formulations, including prefilled syringes and single-dose vials for subcutaneous administration.
The launch underscores Biocon’s growing global footprint in biosimilars, supported by its integrated model spanning research, manufacturing and commercialisation. The company currently operates in over 120 countries and has commercialised multiple biosimilar products across key therapeutic areas.
Industry analysts note that the interchangeable designation provides a competitive advantage, allowing pharmacy-level substitution and potentially accelerating adoption in the U.S. market.
The development aligns with Biocon’s broader strategy of expanding access to affordable biologics, while strengthening its position in high-growth therapeutic segments such as oncology, immunology and bone health.
