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Sandoz: ROSALIA Study With Proposed Biosimilar Denosumab Meets Primary Endpoints

Sandoz reported positive results from the integrated ROSALIA phase I/III clinical trial study for its proposed biosimilar denosumab. The company said the results from the study confirmed 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.

In July 2022, the application for the multiple sclerosis proposed biosimilar natalizumab was accepted for review by the FDA and European Medicines Agency. In June 2022, EMA and FDA accepted for review Sandoz applications for the high-concentration formulation 100 mg/mL of its biosimilar adalimumab.

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