Biocon Announces U.S. Commercial Launch of Denosumab Biosimilars Bosaya™ and Aukelso™

Biocon Announces U.S. Commercial Launch of Denosumab Biosimilars Bosaya™ and Aukelso™​

Biocon Limited, a global biopharmaceutical company, announced the commercial launch of its denosumab biosimilars, Bosaya™ and Aukelso™, in the United States. The availability of these products comes following U.S. FDA approval in September 2025, which granted them an interchangeable designation.

Bosaya™ is a biosimilar to Prolia®, while Aukelso™ is a biosimilar to Xgeva®. Both products are now available by prescription nationwide through specialty pharmacies and healthcare providers.

Shreehas Tambe, CEO & Managing Director of Biocon Limited, stated that the U.S. introduction marks a strategic expansion of the company's biosimilars portfolio. He noted that these therapies aim to broaden access to high-quality, affordable treatment options for patients dealing with serious bone conditions.

Denosumab products are critical in treating osteoporosis and bone complications associated with cancer. In 2024, denosumab products generated approximately $5 billion in U.S. sales, underscoring the continuous need for accessible treatment options in this segment.

The biosimilars are available in the following presentations:

Overview of Medical Conditions​

Osteoporosis, a chronic disease that weakens bones, affects an estimated 10 million adults over age 50 in the United States. Additionally, bone metastases are reported as a common complication of advanced cancer, affecting more than 330,000 patients annually in the U.S.

Denosumab is a human monoclonal antibody that works by targeting and binding to Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL), a substance essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. By blocking RANKL, the drug helps reduce bone breakdown, thereby increasing bone mass and strength.

Adverse Reactions and Warnings​

For Bosaya™ (denosumab-kyqq), patients with advanced chronic kidney disease face a greater risk of severe hypocalcemia. Prior to use, evaluation for Chronic Kidney Disease-Mineral Bone Disorder (CKD-MBD) is advised, and treatment should be supervised by a healthcare provider specializing in CKD-MBD management.

For Aukelso™ (denosumab-kyqq), the key warnings include the risk of severe symptomatic hypocalcemia, for which calcium and vitamin D supplementation is necessary before initiation. Patients should also undergo an oral examination before starting Aukelso™ and monitor for signs of Osteonecrosis of the Jaw (ONJ).

The use of denosumab products requires monitoring for several conditions, including potential atypical femoral fractures and multiple vertebral fractures following treatment discontinuation.

Use in Specific Populations​

Regarding patient populations, the products carry specific guidelines:

• Pregnant Women and Females of Reproductive Potential: Caution is advised, and the use of effective contraception is recommended both during therapy and for at least 5 months after the last dose of BOSAYA.
• Renal Impairment: Patients with advanced chronic kidney disease (eGFR<30 mL/min/1.73 m2), including dialysis-dependent patients, are noted to be at increased risk for hypocalcemia.

Biocon Limited provides detailed information regarding the biosimilars, which are available in the United States.

BIOCON Stock Price Movement​

Biocon Limited shares today slipped by 4.15% to settle at ₹340.05. The stock saw significant movement, with total volume reaching 15.93 million shares by the close.

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