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The FDA approved two denosumab biosimilars as interchangeable alternatives to Prolia and Xgeva for osteoporosis and cancer-related bone issues.
The U.S. FDA has approved Biocon Biologics' denosumab biosimilars, Bosaya and Aukelso, as interchangeable alternatives to Prolia and Xgeva.
Both are approved for similar uses, including treating osteoporosis in high-risk patients and preventing bone complications in cancer patients.
They demonstrated comparable safety, quality, and efficacy to the reference drugs.
The approval expands access to affordable biologic therapies, with both biosimilars receiving provisional interchangeability status.
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La FDA aprobó dos biosimilares de denosumab como alternativas intercambiables a Prolia y Xgeva para la osteoporosis y problemas óseos relacionados con el cáncer.