Gedeon Richter receives positive opinion from CHMP for marketing authorisation for Junod and Yaxwer its denosumab biosimilars for bone disease and osteoporosis

Gedeon Richter announces  that it received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the EMA recommending that marketing authorization be granted in Europe for Junod and Yaxwer, its biosimilar denosumab products, for all indications of the reference medicines Prolia and Xgeva of Amgen. Both Junod and Yaxwer contain denosumab, a human monoclonal antibody (IgG2) that targets and binds with high affinity to RANKL, inhibiting its interaction with the RANK receptor on osteoclasts and their precursors. This mechanism prevents osteoclast formation, function, and survival, thereby reducing bone resorption in both cortical and trabecular bone. The products are administered subcutaneously, with dosing regimens and presentations identical to those of the reference medicines.

“The positive CHMP opinion for Junod and Yaxwer paves the way for EU marketing authorisation of these vital medicines, marking Richter’s first monoclonal antibody biosimilar approval and a significant milestone in our commitment to expanding access to high-quality, affordable biologic therapies for patients across Europe. Junod and Yaxwer enhance our bone health portfolio, joining Terrosa,our marketed teriparatide biosimilar product addressing the considerable burden of bone loss and cancer-related skeletal complications and improving patients’ lives.” said Dr. Erik Bogsch, Head of the Biotechnology Business Unit at Richter.