These highlights do not include all the information needed to use DENOSUMAB-BMWO safely and effectively. See full prescribing information for DENOSUMAB-BMWO. DENOSUMAB-BMWO injection, for subcutaneous use Initial U.S. Approval: 2025 Denosumab-bmwo is biosimilarBiosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of Denosumab-bmwo has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. to XGEVA® (denosumab)

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These highlights do not include all the information needed to use DENOSUMAB-BMWO safely and effectively. See full prescribing information for DENOSUMAB-BMWO. DENOSUMAB-BMWO injection, for subcutaneous use Initial U.S. Approval: 2025 Denosumab-bmwo is biosimilarBiosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of Denosumab-bmwo has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. to XGEVA® (denosumab)

Medication label

Why this: Advisory · dailymed-prescription

Denosumab-bmwo is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. Denosumab-bmwo is indicated for the treatment of 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 [see Clinical Trials (14.2)]. Denosumab-bmwo is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

generic_name: denosumab-bmwo
product_names: denosumab-bmwo
ndc: 72606-059, 72606-059-01
group: drugs
license: us-gov-pd
attribution: Courtesy of the National Library of Medicine
reviewed: 2026-09-18
language: en