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Shanghai Henlius’ & Organon’s Biosimilar Denosumab Applications Validated by EMA

May 24, 2024

On 24 May 2024, Shanghai Henlius and Organon announced that the European Medicines Agency (EMA) validated Henlius’ and Organon’s applications for denosumab as biosimilars to Amgen’s Prolia® and Xgeva®.  The applications are based on Phase 3 trials confirming HLX14 is equivalent in efficacy, safety, tolerability and immunogenicity to Prolia® in postmenopausal women with osteoporosis at high risk for fracture.

In June 2022, Shanghai Henlius entered into a licence agreement with Organon regarding HLX14 (and pertuzumab) under which Organon has exclusive global commercialisation rights for all countries except China, Hong Kong, Macau and Taiwan.

This news comes two days after the European Commission approved Sandoz’s Wyost® and Jubbonti® as the first EU denosumab biosimilars.