FDA Approves Denosumab-Kyqq as Biosimilar for Prolia, Xgeva

The FDA approved denosumab-kyqq (Bosaya, Aukelso) as biosimilars for denosumab (Prolia, Xgeva, respectively) as subcutaneous use in single-dose vials. The biosimilar was also granted provisional interchangeability designation, making the drug substitutable at the pharmacy level.¹

The FDA also grants the biosimilar provisional interchangeability designation, making the drug substitutable at the pharmacy level. | Image Credit: lexiconimages - stock.adobe.com

"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.¹ “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."

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

The most common adverse reactions for Bosaya included back pain, pain in extremities, hypercholesterolemia, musculoskeletal pain, cystitis, arthralgia, nasopharyngitis, hypertension, bronchitis, and headache. For Aukelso, adverse reactions included fatigue/asthenia, hypophosphatemia, nausea, diarrhea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, headache, arthralgia, pain in extremities, dyspnea, decreased appetite, vomiting, and constipation.¹

The FDA approved denosumab-nxxp (Bildyos, Bilprevda), denosumab-bnht (Conexxence, Bomyntra), denosumab-bmwo (Stoboclo, Osenvelt), and denosumab-dssb (Ospomyv; Xbryk) so far in 2025. Denosumab-dssb was also granted interchangeability status.^2-5

The first biosimilar for denosumab was approved in 2024, and denosumab-bbdz (Wyost, Jubboti) was the first approved denosumab biosimilar granted interchangeability status.³ Denosumab-kyqq was the sixth biosimilar for denosumab approved by the FDA.

Denosumab is a human monoclonal antibody that targets and binds to receptor activator of nuclear factor kappa-B ligand (RANKL), which helps the formation, function, and survival of osteoclasts. When blocking RANKL, the drug reduces bone breakdown and increases bone mass and strength, according to the news release.¹

READ MORE: Biosimilar Resource Center

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REFERENCES

1. Biocon Biologics receives US Food and Drug Administration approval for Bosaya and Aukelso, denosumab biosimilars. News release. Biocon Biologics. 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. Gallagher A. FDA approves biosimilars for Prolia, Xgeva. Drug Topics. September 2, 2025. Accessed September 17, 2025. https://www.drugtopics.com/view/fda-approves-biosimilars-for-prolia-xgeva

3. Gallagher A. FDA approves denosumab-bnht as biosimilar to Prolia, Xgeva. Drug Topics. March 27, 2025. Accessed September 17, 2025. https://www.drugtopics.com/view/fda-approves-denosumab-bnht-as-biosimilar-to-prolia-xgeva

4. Gallagher A. FDA approves denosumab-bmwo as biosimilar to Prolia, Xgeva. Drug Topics. March 4, 2025. Accessed September 17, 2025. https://www.drugtopics.com/view/fda-approves-denosumab-bmwo-as-biosimilar-to-prolia-xgeva

5. Gallagher A. FDA approves denosumab-dssb as biosimilar for Prolia, Xgeva. Drug Topics. February 17, 2025. Accessed September 17, 2025. https://www.drugtopics.com/view/fda-approves-denosumab-dssb-as-biosimilar-for-prolia-xgeva