EMA accepts marketing authorization applications for proposed biosimilar Denosumab: Sandoz
Denosumab is a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue).;
Basel: Sandoz has announced that the European Medicines Agency (EMA) has accepted the marketing authorization applications (MAA) for proposed biosimilar denosumab for regulatory review.
The two applications include all indications covered by the reference medicines Prolia (denosumab) and Xgeva (denosumab), respectively, for treating a variety of conditions, including osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal related complications in cancer that have spread to the bone, and giant cell tumor of the bone.
“Sandoz is one of the first to have its applications for a proposed biosimilar denosumab accepted by the EMA. If approved, this has the potential to provide people living with osteoporosis and cancer of the bone or bone metastasis access to a cost-effective and high-quality treatment option.” said Florian Bieber, Development Platform Head Biopharmaceuticals and Chief Medical Officer, Sandoz. “This news follows the recent application acceptance by the US Food and Drug Administration and supports our continued commitment to providing expanded access to life-changing treatments, while also helping over-burdened healthcare systems generate savings.”
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