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Junod and Yaxwer have been approved for all indications of the reference drug. Gedeon Richter’s drugs can be used to treat several diseases. The European Commission has granted marketing authorization for Richter Gedeon’s Junod and Yaxwer biosimilar denosumab products, reported VG.hu.
The Commission’s decision follows a positive opinion issued by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on April 25. The committee’s approval of the monoclonal antibody biosimilar products is a significant milestone for Richter. Junod and Yaxwer are approved for all indications of the reference medicines, including:
• the treatment of osteoporosis in postmenopausal women
• the prevention of skeletal-related events in cancer patients with bone metastases
• the treatment of inoperable giant cell tumors of the bone.
Gedeon Richter announced that the approval is based on a comprehensive development program that demonstrates biological similarity to the reference products in terms of quality, safety, and efficacy.
Both Junod and Yaxwer contain denosumab, a human monoclonal antibody (IgG2) that targets RANKL and binds to it with high affinity, inhibiting its interaction with the RANK receptor on osteoclasts and their precursors. This mechanism prevents the formation, function, and survival of osteoclasts, thereby reducing bone resorption in both cortical and trabecular bone. The products are administered subcutaneously, and the dosing regimen and packaging are the same as those of the reference medicines.
Via VG.hu; Featured Image: Facebook/Richter Gedeon Nyrt.