Gedeon Richter and Hikma Pharmaceuticals Receive the US FDA’s Approval for Enoby and Xtrenbo (Biosimilar, Prolia & Xgeva)

Shots:

• The US FDA has approved Enoby (RGB-14-P) & Xtrenbo (RGB-14-X), biosimilar versions of Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders
• Approval was based on extensive clinical data submitted by Hikma, incl. analytical, non-clinical & clinical studies, which showed comparable quality, efficacy, safety & immunogenicity of Enoby & Xtrenbo to reference denosumab
• Hikma & Richter entered a license & commercialization deal in Dec 2021, with Richter handling product development & manufacturing, while Hikma manages FDA registration & holds exclusive US commercialization rights

Ref: Gedeon Richter | Image: Gedeon Richter & Hikma Pharmaceuticals | Press Release

Related News:- Gedeon Richter Receives CHMP’s Positive Opinion for Junod and Yaxwer (Biosimilars, Prolia and Xgeva)

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