Biocon Biologics Set to Launch Denosumab Biosimilars in the U.S. Market

On October 1, 2025, Biocon Biologics Ltd., a leader in the global biosimilars industry, announced that it has successfully established a market entry date for its denosumab biosimilars, Bosaya™ and Aukelso™, in the United States. The breakthrough comes after a pivotal settlement and licensing agreement with Amgen Inc., paving the way for Biocon Biologics to commercialize these products. This milestone reflects Biocon's commitment to expanding access to high-quality healthcare solutions in key markets.

Background on the Products

Bosaya™ and Aukelso™ are designed as biosimilars to Amgen’s Prolia® and Xgeva®, which are widely used in treating osteoporosis and various cancer-related bone ailments. Specifically, Bosaya™ is formulated as a 60 mg/mL injection delivered via a single-dose prefilled syringe, while Aukelso™ comes as a 120 mg/1.7 mL injection intended for subcutaneous use, available in a single-dose vial. Both biosimilars received approval from the U.S. Food and Drug Administration (FDA) in September 2025, including provisional interchangeability designation, making them highly anticipated additions to the market.

According to Shreehas Tambe, CEO and Managing Director of Biocon Biologics, this agreement marks a significant point in their journey, as it allows them to introduce these essential therapies to healthcare practitioners and patients in the United States. The company aims to strengthen its oncology portfolio and reach more individuals who require high-quality biologic treatments.

Significance of Denosumab

Denosumab, the active ingredient in both Bosaya™ and Aukelso™, is a human monoclonal antibody that critically targets and binds to RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand). This action efficiently dampens the activity of osteoclasts, the cells responsible for bone resorption. Consequently, denosumab is effective in increasing bone mass and overall strength, crucial for populations at risk for bone fractures due to conditions like osteoporosis.

Globally, osteoporosis affects an estimated 10 million adults over the age of 50 in the U.S. alone, making this a vital area of treatment. Furthermore, Bone metastases complicate the health of over 330,000 cancer patients each year, demonstrating the urgent need for efficacious therapy alternatives. Bosaya™ is expected to benefit postmenopausal women at high risk for fractures, men suffering from osteoporosis, and patients undergoing certain cancer treatments, while Aukelso™ will play a crucial role in preventing skeletal-related events in patients with multiple myeloma and those with bone metastases from solid tumors.

Ensuring Patient Safety

Clinical trials have shown that Bosaya™ and Aukelso™ are well-aligned with the safety and efficacy of their reference products, providing comparable results necessary for the successful management of the aforementioned conditions. Both biosimilars will utilize the same Risk Evaluation and Mitigation Strategy (REMS) plan as Prolia®, thereby ensuring that healthcare providers and patients are adequately informed about potential risks, including severe hypocalcemia associated with chronic kidney disease, particularly in advanced cases.

In conclusion, with the anticipation of launching Bosaya™ and Aukelso™ into the U.S. market, Biocon Biologics is positioning itself not just as a participant in the healthcare industry but as a pivotal force for change. By continuously innovating and providing affordable access to high-quality biologics, they reaffirm their leadership role in the biosimilar sector, ensuring that more patients receive the transformative therapies they need.