EMA accepts Richter’s MAAs for biosimilar denosumab

19 July 2024

Hungary’s largest drugmaker Gedeon Richter (RICHT: HB) today announced that the European Medicines Agency (EMA) has accepted the company’s two marketing authorization applications (MAAs) for its proposed biosimilar to denosumab.

Denosumab is indicated for treating osteoporosis in postmenopausal women, preventing skeletal-related complications in cancer that has spread to the bone, and treating unresectable giant cell tumor of the bone.

Richter’s two MAAs include all indications covered by the reference biologics, namely US biotech major Amgen’s (Nasdaq: AMGN) Xgeva for bone cancer and Prolia for osteoporosis, but if approved they will not be the first generic of denosumab to come to the market..

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