HCP Live March 5, 2024
The decision was based on clinical studies demonstrating no clinically meaningful differences between the biosimilar and its reference product.
The US Food and Drug Administration (FDA) has announced the approval of denosumab-bddz (Wyost, Jubbonti), the first FDA-approved, interchangeable denosumab biosimilars, according to a press release.1 The drugs are approved for all indications of the reference drug (Xgeva).
The decision was based on clinical studies demonstrating no clinically meaningful differences between the biosimilar and bio-originator. Both biosimilars have the same dosage form, dosing regimen, and route of administration as the reference product, a human monoclonal antibody developed to bind to the receptor activator of nuclear factor kappa-Β ligand (RANKL) protein.
About Wyost (denosumab-bbdz)
Denosumab-bddz 120 mg/1.7 mL (70 mg/mL) injection is...
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