Posted by Michael Wonder on 13 Dec 2024
Hikma and Richter announce FDA submission acceptance for denosumab biosimilar products
12 December 2024 - Gedeon Richter and Hikma Pharmaceuticals today announced that the US FDA had accepted for review the biologics license applications for RGB-14, a denosumab biosimilar candidate comprising two biosimilar products referencing Prolia and Xgeva, a human monoclonal antibody for the treatment of osteoporosis and fractures due to bone metastasis.
In December 2021, Hikma entered an exclusive license agreement to commercialise Richter’s denosumab in the US.
