Gedeon Richter and Hikma Receive FDA Biosimilar Approval for Denosumab

Enoby and Xtrenbo are the latest denosumab biosimilars to receive FDA approval, referencing Prolia and Xgeva, respectively. The approval, announced October 14, is the seventh denosumab biosimilar. Both are designated denosumab-qbde. Enoby is approved to treat the principal osteoporosis-related indications of Prolia, and Xtrenbo’s approval matches the oncology-related skeletal indications of Xgeva. Gedeon Richter’s partner … Continue reading Gedeon Richter and Hikma Receive FDA Biosimilar Approval for Denosumab