Biocon Announces U.S. Commercial Launch of Bosaya™ and Aukelso™, Denosumab Biosimilars
BENGALURU, India & BRIDGEWATER, N.J.--( BUSINESS WIRE)--Biocon Limited (BSE: 532523; NSE: BIOCON), an innovation‑led global biopharmaceutical company, today announced the commercial launch of Bosaya™ (denosumab-kyqq) and Aukelso™ (denosumab-kyqq) in the United States. Bosaya™ (biosimilar to Prolia ®) and Aukelso™ (biosimilar to Xgeva ®) are now available by prescription nationwide through specialty pharmacies and healthcare providers. Both products have been previously approved and granted interchangeable designation by the U.S. Food and Drug Administration in September 2025, allowing substitution at the pharmacy level in accordance with state laws.
Denosumab products play a critical role in bone health, treating osteoporosis and bone complications associated with cancer.
Shreehas Tambe, CEO & Managing Director, Biocon Limited, said, “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. These therapies broaden access to high‑quality, affordable treatment options for patients living with serious bone conditions. This milestone underscores Biocon’s strength as a portfolio development engine and our focus on building the world’s most scalable access platform—advancing life‑changing medicines for patients and health systems across the United States and around the world.”
Denosumab products play a critical role in bone health, treating osteoporosis and bone complications associated with cancer. In 2024, denosumab products generated approximately $5 billion in U.S. sales, reflecting the growing need for accessible treatment options.
Both biosimilars will be available in the most common presentations:
Epidemiology:
Osteoporosis is a chronic disease that weakens bones, making them fragile and more prone to fracture. In the United States, approximately 10 million adults over age 50 are estimated to have osteoporosis, with another 44 million at risk due to low bone density. 3,4 One in two women and up to one in four men over age 50 will break a bone in their lifetime due to osteoporosis. 5
Bone metastases are a common complication of advanced cancer, affecting more than 330,000 patients annually in the United States. 6 Skeletal complications can significantly impair quality of life and increase healthcare burden. 7
Giant cell tumor of bone (GCTB) is a rare, locally aggressive benign tumor that primarily affects young adults. While noncancerous, it can cause severe pain, fractures, and disability.
About BOSAYA 1 and AUKELSO 2:
Denosumab is a human monoclonal antibody that targets and binds to Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL). RANKL is essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. By blocking RANKL, denosumab reduces bone breakdown, increasing bone mass and strength.
About BOSAYA (denosumab-kyqq)
WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE
See full prescribing information for complete boxed warning.
Prior to initiating BOSAYA in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with BOSAYA in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD.
Warnings and Precautions:
Adverse reactions:
Use in Specific Populations:
About AUKELSO (denosumab-kyqq)
Warnings and Precautions:
Adverse Reactions:
Use in Specific Populations:
Please refer to the full Patient Information for detailed safety information. To report SUSPECTED ADVERSE REACTIONS, contact Biocon at 1-833-986-1468.
1 BOSAYA. Prescribing information. Biocon Biologics Inc; 2025.
2 AUKELSO. Prescribing information. Biocon Biologics Inc; 2025.
3 Bone Health and Osteoporosis Foundation. “Osteoporosis Fast Facts.” Accessed: September 14, 2025. https://www.bonehealthandosteoporosis.org/wp-content/uploads/Osteoporosis-Fast-Facts-2.pdf
4 American Medical Association. “What doctors wish patients knew about osteoporosis.” Accessed: September 14, 2025. Published: May 3, 2024. https://www.ama-assn.org/public-health/prevention-wellness/what-doctors-wish-patients-knew-about-osteoporosis
5 Hernandez RK, Adhia A, Wade SW, O’Connor E, Arellano J, Francis K, Alvrtsyan H, Million RP, Liede A. Prevalence of bone metastases and bone-targeting agent use among solid tumor patients in the United States. Clin Epidemiol. 2015 Jul 17;7:335-45.
6 Moffitt Cancer Center. “Bone Metastasis.” Accessed: September 14, 2025. https://www.moffitt.org/cancers/bone-metastasis/
7 American Cancer Center. “Bone Metastases.” Accessed: September 14, 2025. https://www.cancer.org/cancer/managing-cancer/advanced-cancer/bone-metastases.html
About Biocon Limited
Biocon Limited (BSE: 532523, NSE: BIOCON) is a global biopharmaceutical company driven by its purpose to provide affordable, life-changing medicines to patients worldwide. Headquartered in Bengaluru, India, Biocon addresses some of the world’s most pressing healthcare challenges across chronic and non-communicable diseases by offering both biosimilars and generics at scale across geographies. Through this diversified portfolio, Biocon focuses on areas of high unmet need, spanning key therapy areas including diabetes, oncology, obesity, cardiovascular diseases, immunology, ophthalmology, and bone health. The Company has pioneered several industry firsts that have helped shape the global biosimilars landscape. To date, the company has commercialized 12 biosimilar products and 30+ generic formulations globally. It has robust research and development pipeline of 20+ biosimilar assets, as well as GLP-1 peptides and other complex generics. With an integrated lab-to-patient model, Biocon brings together research and development, manufacturing, and commercial capabilities to ensure reliable and scalable supply of medicines. The company operates in more than 120 countries, supported by seven manufacturing sites, three R&D sites, 18 offices worldwide, and a workforce of over 9,500 employees. Biocon has been included in the S&P Global Sustainability Yearbook 2026 for the fourth consecutive year, underscoring its commitment to sustainable and responsible growth. Website: www.biocon.com Follow us on X: @bioconlimited LinkedIn: Biocon
Forward-Looking Statements: Biocon
This press release may include statements of future expectations and other forward-looking statements based on management’s current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release.
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