FDA accepts submission for Hungarian pharmaceutical company Richter denosumab biosimilar

Hungarian pharmaceutical company Gedeon Richter and UK-based peer Hikma on Thursday announced that the United States Food and Drug Administration (FDA) accepted an application for Richter’s denosumab biosimilar candidate.

Richter application accepted by FDA

The candidate, RGB-14, comprises two biosimilar products referencing Prolia and Xgeva. Richter‘s denosumab is a human monoclonal antibody for the treatment of osteoporosis and fractures due to bone metastasis.

In December 2021, Hikma entered into an exclusive license agreement to commercialise denosumab in the US.

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