Biocon Rolls Out Bosaya, Aukelso Denosumab Biosimilars Across U.S.

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Biocon launches interchangeable denosumab biosimilars Bosaya and Aukelso in the U.S. for osteoporosis and cancer-related bone complications; see USPI for safety, warnings, and ADRs.

By: Pharmacally Medical News Desk

Biocon Limited announced the commercial launch of Bosaya™ (denosumab-kyqq) and Aukelso™ (denosumab-kyqq) in the United States. The products, biosimilars to Prolia® and Xgeva®, respectively, are now available nationwide by prescription through specialty pharmacies and healthcare providers. Both therapies received U.S. Food and Drug Administration approval with interchangeable designation in September 2025, allowing pharmacy-level substitution in accordance with state laws.

Portfolio Expansion in Bone Health and Oncology

The launch expands Biocon’s biosimilars portfolio in oncology and immunology. The company said the availability of Bosaya and Aukelso is intended to broaden access to more affordable treatment options for patients with serious bone-related conditions.

CEO and Managing Director Shreehas Tambe noted that the U.S. introduction represents a strategic step in scaling Biocon’s biosimilars platform and strengthening access to biologic therapies for patients and health systems.

Indications and Market Context

Denosumab therapies are widely used to manage osteoporosis and prevent skeletal complications associated with cancer, including bone metastases and giant cell tumor of bone. In 2024, denosumab products generated approximately $5 billion in U.S. sales, reflecting substantial clinical demand for bone-protective biologics.

Available Presentations

Both biosimilars are offered in commonly used dosage forms:

  • Bosaya™ (biosimilar to Prolia®): 60 mg/mL subcutaneous injection in a prefilled syringe
  • Aukelso™ (biosimilar to Xgeva®): 120 mg/1.7 mL (70 mg/mL) subcutaneous injection in a single-dose vial

Disease Burden

Osteoporosis affects an estimated 10 million adults over age 50 in the United States, with another 44 million at risk due to low bone density. Approximately one in two women and up to one in four men over age 50 will experience an osteoporosis-related fracture during their lifetime.
Bone metastases affect more than 330,000 patients annually in the U.S., often leading to fractures, pain, and reduced quality of life. Giant cell tumor of bone, although rare and typically benign, can cause significant bone destruction, disability, and fractures.

Mechanism of Action

Denosumab is a human monoclonal antibody that binds to receptor activator of nuclear factor kappa-B ligand (RANKL). RANKL plays a key role in the formation and survival of osteoclasts, the cells responsible for bone resorption. By inhibiting RANKL, denosumab reduces bone breakdown and increases bone mass and strength.

Safety Information

Prescribing information for both denosumab biosimilars includes warnings for severe hypocalcemia, hypersensitivity reactions, osteonecrosis of the jaw, and embryo-fetal toxicity. Patients with advanced chronic kidney disease are at increased risk for severe hypocalcemia, and calcium and vitamin D supplementation is recommended. Additional risks include serious infections, dermatologic reactions, and atypical femoral fractures reported with denosumab products.

For complete safety details, including Warnings and Precautions and Adverse Reactions, refer to the full U.S. prescribing information for:

Reference

Biocon Announces U.S. Commercial Launch of Bosaya™ and Aukelso™, Denosumab Biosimilars, 07 April 2026, https://www.biocon.com/biocon-announces-u-s-commercial-launch-of-bosaya-and-aukelso-denosumab-biosimilars/


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