Budapest-based pharmaceutical company Gedeon Richter Plc. has received positive opinion from CHMP for marketing authorization for Junod and Yaxwer, its biosimilar denosumab products for bone disease and osteoporosis.
Budapest-based pharmaceutical company Gedeon Richter Plc. has announced on the website of the Budapest Stock Exchange that it received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending that marketing authorization be granted in Europe for Junod and Yaxwer, its biosimilar denosumab products for bone disease and osteoporosis, for all indications of the reference medicines Prolia and Xgeva of Amgen.
Denosumab is indicated for treating osteoporosis in postmenopausal women, preventing skeletal-related complications in cancer that has spread to the bone, and treating unresectable giant cell tumor of the bone.
“The positive CHMP opinion for Junod and Yaxwer paves the way for EU marketing authorization 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,” Dr. Erik Bogsch, Head of the Biotechnology Business Unit at Richter, pointed out.
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