On October 30, 2024, Shanghai Henlius Biotech and Organon announced that the FDA has accepted the Biologic License Application (BLA) for HLX14, a proposed biosimilar to PROLIA/XGEVA (denosumab). In 2022, Shanghai Henlius Biotech granted Organon exclusive commercialization rights for HLX14 in the U.S., EU, and Canada.
The filing for HLX14 is supported by data from studies including analytical assessments and two clinical trials. The first study was a two-part phase 1 trial in healthy adult males in China. Part 1 was an open-label pilot study, comparing HLX14's pharmacokinetics with EU-sourced PROLIA after subcutaneous injection, setting the foundation for Part 2. Part 2 was a double-blind, four-arm study examining HLX14's pharmacokinetic similarity to PROLIA sourced from the U.S., EU, and China. The second trial, a phase 3 international study, assessed HLX14's efficacy, safety, tolerability, and immunogenicity compared to EU-sourced PROLIA in postmenopausal women with osteoporosis at high risk of fracture.
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