By: IPP Bureau
Last updated : April 08, 2026 9:03 am
Interchangeable biosimilars to Prolia and Xgeva target osteoporosis and cancer-related bone complications in a $5 billion U.S. market
Biocon Limited has commercially launched Bosaya™ and Aukelso™, its interchangeable denosumab biosimilars, in the United States, marking a significant expansion of its biosimilars franchise in bone health and oncology.
The products, approved by the U.S. FDA in September 2025, are now available nationwide through specialty pharmacies and healthcare providers.
Bosaya is the biosimilar version of Prolia, indicated for osteoporosis and other bone-loss conditions, while Aukelso references Xgeva, used in skeletal complications arising from advanced cancers and giant cell tumour of bone. Their interchangeable designation enables pharmacy-level substitution under applicable state laws, a move expected to accelerate adoption and improve affordability.
The launch gives Biocon access to a high-value U.S. denosumab market that generated nearly $5 billion in sales in 2024, while addressing a sizeable patient population. Around 10 million adults in the U.S. are estimated to live with osteoporosis, and over 330,000 cancer patients annually experience bone metastasis, underscoring the unmet need for lower-cost biologic alternatives.
“The U.S. introduction of Bosaya and Aukelso marks a strategic expansion of our biosimilars portfolio, building on our established leadership in oncology and immunology,” said Shreehas Tambe, CEO & Managing Director, Biocon Limited. He added that the launch strengthens the company’s ambition to build a scalable access platform for life-changing therapies across global markets.
The two products will be offered in widely used formats: Bosaya as a 60 mg/mL prefilled syringe for subcutaneous injection, and Aukelso as a 120 mg/1.7 mL single-dose vial, aligning with the most common prescribing patterns in the U.S. market.
The commercialization further deepens Biocon’s presence in the global biosimilars space, where the company has been steadily expanding beyond diabetes and immunology into oncology, obesity, and bone health—therapy areas with strong demand visibility and long-term growth potential.