Sandoz announces positive results for biosimilar Denosumab

Sandoz today announced further progress on its biosimilar pipeline, with the release of positive results from the integrated Rosalia phase-I/III clinical trial study for its proposed biosimilar Denosumab.

The results from the integrated phase-I/III study confirm the biosimilar matches the reference medicine in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in the respective indications; and contributes to demonstration of similarity, which is the basis for use in all indications, Sandoz said in a statement.

The results came soon after Sandoz confirmed acceptance of licence applications for two other proposed biosimilars. In July 2022, the application for the first-of-a-kind multiple sclerosis proposed biosimilar Natalizumab was accepted for review by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). In June 2022, the EMA and FDA accepted for review Sandoz applications for the high-concentration formulation 100 mg/mL (HCF) of its biosimilar Adalimumab, the statement added.