BENGALURU, India & BRIDGEWATER, N.J. – September 17, 2025 –
Biocon Biologics Ltd. (BBL), a global leader in biosimilars and subsidiary of Biocon Ltd., today announced that the U.S. Food and Drug Administration (FDA) has approved Bosaya™ (denosumab-kyqq) and Aukelso™ (denosumab-kyqq), interchangeable biosimilars referencing Amgen’s Prolia® and Xgeva®. This dual approval marks a major milestone in bone health and oncology care, positioning Biocon Biologics as a key player in expanding access to life-saving biologics in the United States.
Science Significance
Denosumab is a fully human monoclonal antibody that binds to RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand), a key driver of osteoclast activity and bone resorption. By blocking RANKL, denosumab reduces bone breakdown and strengthens skeletal integrity. Bosaya™ is approved for osteoporosis and bone loss indications, while Aukelso™ is approved for oncology settings such as multiple myeloma, bone metastases, giant cell tumor of bone, and hypercalcemia of malignancy.
The FDA’s scientific assessment confirmed that both biosimilars demonstrated comparable quality, safety, and efficacy to their reference products. Importantly, Bosaya™ carries the same Risk Evaluation and Mitigation Strategy (REMS) as Prolia®, highlighting the importance of monitoring severe hypocalcemia in patients with advanced chronic kidney disease.
Regulatory Significance
The FDA approval comes with a provisional interchangeability designation for both Bosaya™ and Aukelso™, allowing substitution at the pharmacy level where permitted under state laws. This designation represents a regulatory breakthrough, as interchangeable biosimilars remain rare in the U.S. market.
Advertisement
Shreehas Tambe, CEO & Managing Director of Biocon Biologics, stated, “The FDA’s approval of Bosaya™ and Aukelso™ is a significant milestone in our mission to expand access to critical biologic therapies. This achievement underscores our scientific and regulatory capabilities and reinforces our commitment to delivering high-quality biosimilars that support sustainable healthcare systems and improve patient outcomes.”
Business Significance
The U.S. market for denosumab is substantial. According to IQVIA National Sales Perspectives Data, Prolia® and Xgeva® together generated nearly $5 billion in U.S. sales in 2024. With Bosaya™ and Aukelso™, Biocon Biologics now enters a high-value therapeutic area that combines osteoporosis care with oncology applications.
This launch is expected to strengthen Biocon Biologics’ position in advanced markets, complementing its existing biosimilar portfolio. By offering cost-effective alternatives to blockbuster biologics, the company aims to capture significant market share while contributing to healthcare affordability in the U.S.
Patients’ Significance
Osteoporosis and cancer-related bone disease represent urgent and widespread unmet needs. In the U.S., 10 million adults over 50 live with osteoporosis, and another 44 million are at risk due to low bone density. One in two women and up to one in four men over age 50 will sustain a fracture in their lifetime. Additionally, bone metastases affect more than 330,000 U.S. cancer patients annually, often leading to debilitating skeletal complications.
Bosaya™ provides an affordable biosimilar option for patients at risk of osteoporosis-related fractures, while Aukelso™ addresses skeletal events in advanced cancer care. These approvals will significantly ease financial and therapeutic access burdens for patients and caregivers.
Policy Significance
The FDA’s approval of interchangeable biosimilars aligns with U.S. policy objectives to increase biosimilar adoption and reduce biologics spending. As healthcare systems face rising costs of biologics, biosimilars such as Bosaya™ and Aukelso™ represent a pathway to sustainable access. The approval is expected to support broader policy goals under Medicare Part B and Part D by introducing competition, lowering costs, and expanding treatment choice.
For regulators, payers, and policymakers, this milestone demonstrates how biosimilars can balance innovation with affordability, fostering resilience in the healthcare ecosystem.
Transaction Highlights
Biocon Biologics announced that the U.S. FDA approved Bosaiya (denosumab-kyqq) 60 mg/mL prefilled syringe and Audelos™ (denosumab-kyqq) 120 mg/1.7 mL vial, interchangeable biosimilars referencing Prolia® and Geva. Both products demonstrated comparable efficacy and safety to their reference biologics. Bosaya is indicated for osteoporosis-related conditions, including treatment in postmenopausal women, men with high fracture risk, glucocorticoid-induced osteoporosis, and hormone-related bone loss. Aukes is indicated for the prevention of skeletal-related events in multiple myeloma and solid tumor bone metastases, treatment of giant cell tumor of bone, and hypercalcemia of malignancy refractory to bisphosphonates. Clinical trials confirmed equivalent therapeutic benefit and safety. Importantly, the FDA granted both Bosaiya™ and Aukes a provisional interchangeability designation, enabling substitution at the pharmacy level. With nearly $5 billion in combined U.S. sales for denosumab products in 2024, the approval creates significant opportunities for Biocon Biologics to deliver affordable biosimilars and expand access to patients in need.
Source: Biocon Biologics Press Release
