Hungary AM
Tuesday, Jul 23, 2024, 08:45
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Pharma
Image by LaMography/Moni Lazar
Hungarian pharmaceutical company Gedeon Richter said the European Medicines Agency (EMA) accepted two marketing authorization applications for its proposed biosimilar to denosumab, according to an announcement on the website of the Budapest Stock Exchange.
Richter said that the applications include all indications covered by the reference products Prolia and Xgeva.
Denosumab is indicated for treating osteoporosis in postmenopausal women, preventing skeletal-related complications in cancers that have spread to the bone.
It is also used in treating unresectable giant cell tumors of the bone that cannot be entirely removed through surgery.
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