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news.The European Medicines Agency (EMA) has validated the marketing authorisation applications (MAAs) for HLX14, an investigational biosimilar to Prolia and Xgeva (denosumab). This announcement was made by Shanghai Henlius Biotech and Organon.
Organon has a portfolio of over 60 medicines and products in women's health. Daniel Reche from Pixabay.
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Denosumab has secured approval in several countries and regions under different trade names for a range of several indications such as for osteoporosis treatment in postmenopausal women who are at high risk for fracture, among others.
In 2019, it was estimated that 32 million Europeans aged 50 or above had osteoporosis, of which 25.5 million were women.
The validation of HLX14’s MAAs is based on a comprehensive Phase III clinical trial. This international, randomised, double-blind, parallel-controlled multicentre study was designed to evaluate HLX14’s efficacy, safety, tolerability, and immunogenicity in comparison to the EU-sourced reference denosumab (Prolia) in postmenopausal women with osteoporosis at high risk for fracture.
In 2022, Henlius and Organon entered into a licensing and supply agreement, granting Organon exclusive rights to commercialise two biosimilar candidates, including HLX14.
The agreement encompasses several key markets, including the European Union, the US, and Canada, with the exception of China.
Organon, a global healthcare company, is dedicated to improving women’s health. With a portfolio of over 60 medicines and products in women’s health, Organon is also expanding its biosimilars business and maintains a large franchise of established medicines across various therapeutic areas. The company, with around 10,000 employees, is headquartered in Jersey City, New Jersey.
Henlius is a global biopharmaceutical company focused on delivering biologic medicines to patients worldwide, with a particular emphasis on oncology, autoimmune diseases, and ophthalmic diseases. To date, Henlius has launched five products in China, received marketing approval for two in overseas markets, and has 23 indications approved globally. Additionally, three marketing applications are under review in China and the EU.
The company has established an innovation centre and manufacturing facilities in Shanghai, certified by regulatory authorities in China, the EU, and the US. Henlius boasts a robust product pipeline with over 50 molecules and is actively pursuing immuno-oncology combination therapies, using its proprietary HANSIZHUANG (anti-PD-1 mAb) as a backbone.
