EMA Confirms Henlius & Organon's Marketing Authorization App For Prolia

Shanghai Henlius Biotech, Inc., a global biopharmaceutical company, and Organon reported that the European Medicines Agency (EMA) has approved the marketing authorization applications (MAAs) for HLX14, an experimental Prolia and Xgeva (denosumab) biosimilar.

Denosumab has been approved in several countries and regions under several trade names for a variety of indications, including the treatment of osteoporosis in postmenopausal women at high risk of fracture, among others. In 2019, it was anticipated that 32 million Europeans aged 50 and up had osteoporosis, 25.5 million of whom were women.

Based on an international multicenter, parallel-controlled, randomized, double-blind, phase 3 clinical study, the submissions compared the immunogenicity, safety, tolerability, and efficacy of HLX14 with EU-sourced reference denosumab (Prolia) in postmenopausal women with osteoporosis who were at high risk of fracture.

Henlius and Organon signed a license and supply deal in 2022, giving Organon the sole right to commercialize two biosimilar candidates, including HLX14. The European Union, the United States, and Canada are among the markets covered by the pact. China is not bound by the deal.

Henlius is a multinational biopharmaceutical firm whose mission is to provide patients all over the world with novel, high-quality, and reasonably priced biologic medications, with a particular emphasis on autoimmune, ocular, and cancer treatments.