The European Medicines Agency has accepted the application.Continue reading
Gedeon Richter Plc. 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 two products, the Budapest-based pharmaceutical company has announced on the Budapest Stock Exchange (BÉT) website.
“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.”
said Dr. Erik Bogsch, Head of the Biotechnology Business Unit at Richter.
Denosumab is 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, the company explains. 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.
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,
reads the statement.
Via bet.hu; Featured image: Hungary Today