The proposed denosumab biosimilar, SB16, demonstrated pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence, as well as equivalent efficacy, safety, and immunogenicity compared with the reference product among a cohort of postmenopausal women with osteoporosis for up to 18 months of treatment, according to recent research presented at the 2024 European Congress of Rheumatology (EULAR).

Denosumab, a US Food and Drug Administration (FDA)-approved medication, is indicated to treat postmenopausal women at high risk for fracture, patients with intolerance or inadequate response to other osteoporosis treatments, and patients who will be taking corticosteroids for ≥6 months and are at a high risk for fracture. The drug is also used to increase bone mass in men with osteoporosis at a high risk for fracture and men at a high risk for fracture treated with certain medications for prostate cancer.

Source: MDMag

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