FDA Approves Bosaya and Aukelso, Biosimilars to Reference Denosumab

The FDA approved denosumab-kyqq 60 mg/mL subcutaneous injection (Bosaya) and denosumab-kyqq 120 mg/1.7 mL (70 mg/mL) subcutaneous injection (Aukelso; Biocon Biologics Ltd.), biosimilars to reference denosumab (Prolia and Xgeva, respectively; Amgen). Additionally, the FDA granted provisional interchangeability designation for both biosimilars, ensuring the biosimilars’ use in all FDA-approved indications of the reference products.¹

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Denosumab is a human monoclonal antibody that targets and binds to receptor activator of nuclear factor kappa-B ligand (RANKL), which is essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. By blocking RANKL, denosumab reduces bone breakdown to increase bone mass and strength. It acts as a bone antiresorptive medication and is used to treat osteoporosis in women who have an increased risk for fractures following menopause (Prolia) and to prevent bone problems (eg, fracture, spinal cord compression, or the need for radiation/surgery to bone) in patients with multiple myeloma and bone metastases from tumors (Xgeva).^1-3

Like Prolia, Bosaya is approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture; to increase bone mass in men with osteoporosis at high risk for fracture; for glucocorticoid-induced osteoporosis in men and women at high risk for fracture; to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer; and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. Aukelso is approved for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors; to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity; and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.^1,2

The news release announcing the approvals of Bosaya and Aukelso states that clinical data demonstrated that both biosimilars showcased comparable quality, safety, and efficacy to reference denosumab. Of note, Bosaya was approved with the same Risk Evaluation and Mitigation Strategy plan as Prolia to inform health care professionals and patients of the potential risks of severe hypocalcemia in patients with chronic kidney disease, including patients who are dialysis-dependent.¹

With this action, Bosaya and Aukelso join other notable biosimilars of denosumab, including denosumab-nxxp 60 mg/mL (Bildyos; Shanghai Henlius Biotech, Organon) and 120 mg/1.7 mL (Bilprevda; Shanghai Henlius Biotech, Organon) injections; denosumab-bmwo (Stoboclo; Celltrion); denosumab-bmwo (Osenvelt; Celltrion); denosumab-bnht (Conexxence, Bomyntra; Fresenius Kabi); denosumab-dssb 120-mg vial (Xbryk; Samsung Bioepis Co); and denosumab-dssb 60-mg prefilled syringe (Ospomyv; Samsung Bioepis Co), all of which are approved for all indications of the reference product.^2,3

“The FDA's approval of Bosaya and Aukelso is a significant milestone in our mission to expand access to critical biologic therapies. With Bosaya, we are proud to offer a more affordable treatment option for patients with osteoporosis, and with Aukelso, we are further expanding our oncology care portfolio,” Shreehas Tambe, CEO and managing director of Biocon Biologics, said in a news release. “This achievement underscores our scientific and regulatory capabilities and reinforces our commitment to delivering high-quality biosimilars that support sustainable health care systems and improve patient outcomes.”¹

REFERENCES

1. PR Newswire. Biocon Biologics Receives U.S. Food and Drug Administration Approval for Bosaya™ and Aukelso™, Denosumab Biosimilars. News release. September 17, 2025. Accessed September 17, 2025. https://www.prnewswire.com/news-releases/biocon-biologics-receives-us-food-and-drug-administration-approval-for-bosaya-and-aukelso-denosumab-biosimilars-302559101.html

2. McGovern G. FDA Approves Bildyos and Bilprevda, Biosimilars of Reference Denosumab. Pharmacy Times. September 2, 2025. Accessed September 17, 2025. https://www.pharmacytimes.com/view/fda-approves-bildyos-and-bilprevda-biosimilars-of-reference-denosumab

3. McGovern G. LY01011, Biosimilar of Denosumab, Meets Primary End Point in Study. Pharmacy Times. August 26, 2025. Accessed September 17, 2025. https://www.pharmacytimes.com/view/ly01011-biosimilar-of-denosumab-meets-primary-end-point-in-study