By Adria Calatayud

Novartis's Sandoz said Thursday that the European Medicines Agency has accepted its marketing-authorization application for biosimilar drug denosumab, which is indicated for treating several conditions including osteoporosis in postmenopausal women.

Sandoz, which specializes in off-patent medicines, said denosumab is also indicated for treatment-induced bone loss, prevention of skeletal-related complications in cancer that has spread to the bone and giant cell tumor of the bone.

The application was supported by analytical and clinical data that confirmed that the denosumab biosimilar matched the reference medicine in efficacy and safety among other aspects, Sandoz said.

Write to Adria Calatayud at adria.calatayud@dowjones.com

(END) Dow Jones Newswires

May 25, 2023 01:45 ET (05:45 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.
Novartis (NYSE:NVS)
Gráfico Histórico do Ativo
De Mar 2024 até Abr 2024 Click aqui para mais gráficos Novartis.
Novartis (NYSE:NVS)
Gráfico Histórico do Ativo
De Abr 2023 até Abr 2024 Click aqui para mais gráficos Novartis.