24 May 2024 - Shanghai Henlius Biotech and Organon today announced that the EMA has validated the marketing authorisation applications for HLX14, an investigational Prolia and Xgeva (denosumab) biosimilar.

The submissions were based on a randomised, double-blind, international multi-centre, 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 post-menopausal women with osteoporosis at high risk for fracture.

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