Gedeon Richter Is Latest To File European Denosumab

Follows Closely Behind Fresenius Submission To EMA For Prolia/Xgeva Rivals

Gedeon Richter has revealed that its European filing for a denosumab biosimilar rival to Prolia/Xgeva has been accepted for review by the EMA.

EU flag on file folder
Richter’s filing has been accepted by the EMA • Source: Shutterstock

Gedeon Richter has become the latest firm to throw its hat into the ring for a denosumab biosimilar, after revealing that the European Medicines Agency has accepted for review the firm’s two marketing authorization applications for proposed rivals to Prolia and Xgeva.

Richter said its two MAAs “include all indications covered by the reference biologics,” such as treating osteoporosis in postmenopausal women,...

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