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Novartis: dossier accepted for denosumab biosimilar

( - The generics and biosimilars division of Novartis, Sandoz, has announced that the European Medicines Agency has accepted the dossier for marketing authorisation applications for a biosimilar of denosumab.

Both applications include all indications covered by the reference medicines Prolia and Xgeva, for the treatment of various diseases, including osteoporosis in postmenopausal women and men at increased risk of fracture.

Sandoz says its applications are supported by a comprehensive set of analytical and clinical data, including a Phase I PK/PD similarity study and the ROSALIA Phase I/III integrated clinical trial.

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