STADA wins approvals to bring denosumab biosimilars to patients in Europe
Germany’s STADA Arzneimittel (SAZ: Xetra) has received marketing authorizations from the European Commission (EC) for its Kefdensis and Zvogra denosumab biosimilars.
Kefdensis, referencing Amgen’s (Nasdaq: AMGN) Prolia, received EC approval for treating osteoporosis in postmenopausal women and in men at increased risk of fractures. Zvogra, referencing Amgen’s Xgeva, is authorized for the prevention of skeletal-related events in adults with advanced malignancies involving bone, as well as for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
The EC approvals follow positive opinions adopted in September 2025 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
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