Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization applications (MAAs) for HLX14, an investigational Prolia^® and Xgeva^® (denosumab) biosimilar. Denosumab has been approved in various countries and regions under different trade names for a range of different indications such as for the treatment of osteoporosis in postmenopausal women at high risk for fracture, among others. In 2019, it was estimated that 32 million Europeans ages 50 or above had osteoporosis, 25.5 million of which were women.

The submissions were based on a randomized, double-blind, international multicenter, parallel-controlled phase 3 clinical study that aimed to compare the efficacy, safety, tolerability, and immunogenicity of HLX14 with EU-sourced reference denosumab (Prolia) in postmenopausal women with osteoporosis at high risk for fracture.

In 2022, Henlius entered into a license and supply agreement with Organon granting Organon the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the European Union, the United States, and Canada. An exception to the agreement is China.