Biocon Launches Denosumab Biosimilars Bosaya, Aukelso in US

The two products- Bosaya (biosimilar to Prolia) and Aukelso (biosimilar to Xgeva are now available nationwide by prescription through specialty pharmacies and healthcare providers. Both had earlier received approval from the US Food and Drug Administration (USFDA) in September 2025 along with an interchangeable designation, enabling substitution at the pharmacy level as per state regulations.

Denosumab is a monoclonal antibody that targets RANKL, a key factor involved in bone resorption. By inhibiting this pathway, the therapy helps reduce bone loss, increase bone strength, and manage conditions such as osteoporosis and bone complications associated with cancer.

The launch addresses a large patient population in the US, where around 10 million adults suffer from osteoporosis, with an additional 44 million at risk due to low bone density. Additionally, more than 330,000 patients annually are affected by bone metastases, a common complication of advanced cancers.

Biocon highlighted that denosumab products recorded approximately USD 5 billion in US sales in 2024, underlining the growing demand for cost-effective treatment alternatives. Bosaya is available as a 60 mg/mL prefilled syringe for subcutaneous injection, while Aukelso is offered as a 120 mg/1.7 mL single-dose vial.

Commenting on the development, Shreehas Tambe, CEO and Managing Director of Biocon Limited, said the launch represents a strategic milestone in expanding access to affordable, high-quality therapies for patients with serious bone conditions and reinforces the company’s commitment to building a scalable global access platform.

Biocon Limited, headquartered in Bengaluru, is a global biopharmaceutical company focused on delivering affordable, life-changing medicines across multiple therapeutic areas including oncology, diabetes, cardiovascular diseases, and immunology. The company operates in over 120 countries with a strong portfolio of biosimilars and generics supported by robust research and manufacturing capabilities.