Shots:
- The NMPA has accepted NDA for HLX14, a biosimilar version of denosumab, in the 120mg (1.7mL) per vial strength presentation
- NDA was based on extensive data, incl. analytical similarity studies, non-clinical & clinical comparative studies, where HLX14 at the 120 mg (1.7 mL) per vial strength showed similarity to its reference drug in terms of quality, safety, & efficacy
- HLX14 products Bildyos and Bilprevda received marketing approvals in the US, EU and UK in H2’25, followed by approval in Canada in Mar 2026 under the trade names Bildyos and Tuzemty
Ref: Henlius | Image: Henlius | Press Release
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