Endocrinology · 4 h ago
Phase 3 trial finds HLX14 equivalent to EU-denosumab on key endpoints
In a randomized, double-blind phase 3 trial involving 514 postmenopausal women with osteoporosis at high fracture risk in China, HLX14 was compared with EU-sourced denosumab. The study found equivalence for lumbar-spine bone mineral density change and a bone-turnover marker endpoint, with comparable safety profiles.
- 514 women randomized in a phase 3 equivalence trial
- Week-52 lumbar-spine BMD increased 6.10% versus 5.90%
- Bone-turnover endpoint met prespecified equivalence criteria
- Fracture outcomes were not co-primary endpoints
This randomized, double-blind, multicenter phase 3 trial compared HLX14, a proposed denosumab biosimilar, with EU-sourced denosumab in 514 postmenopausal women aged 60–90 years with osteoporosis and high fracture risk. Participants received two doses over 52 weeks; some were then rerandomized to continue denosumab or switch to HLX14 for a third dose. Co-primary endpoints were percentage change in lumbar-spine bone mineral density (BMD) at week 52 and the area under the effect-time curve for serum C-terminal telopeptide through week 26.
At week 52, lumbar-spine BMD increased by 6.10% with HLX14 and 5.90% with EU-denosumab. The adjusted difference was 0.23%; its confidence intervals fell within the prespecified equivalence margins. The bone-turnover marker endpoint also met the study’s equivalence criteria. Secondary efficacy results and safety profiles were reported as comparable, including after a single switch from EU-denosumab to HLX14.
The findings support biosimilarity on the measured endpoints, but do not establish equivalence in fracture outcomes: BMD and a bone-turnover marker were the co-primary endpoints. The trial was conducted in China, and the article describes HLX14 as a proposed biosimilar; these results alone do not establish regulatory approval or availability. Follow-up for the reported comparison was 52 weeks, with a third-dose period extending to week 78.
In practice
For postmenopausal women with osteoporosis at high fracture risk, this phase 3 trial found HLX14 equivalent to EU-sourced denosumab on lumbar-spine BMD change and a bone-turnover marker, with comparable reported safety. These results support biosimilarity on the measured endpoints, but do not demonstrate equivalent fracture prevention because fracture outcomes were not the co-primary endpoints. HLX14 is described as a proposed biosimilar, and the trial results alone do not establish approval or availability; they do not support changing current treatment choices.
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Osteoporosis International: Denosumab biosimilar HLX14 versus EU-denosumab in postmenopausal women at high fracture risk: a randomized, double-blind, multicenter phase 3 trial ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.