Denosumab biosimilar HLX14 versus EU-denosumab in postmenopausal women at high fracture risk: a randomized, double-blind, multicenter phase 3 trial

Xin, L; Li, Z; Zhang, J; Xia, Q; Jin, P; Xue, Q; Zheng, X; Tang, X; Yuan, Z; Shen, L; Duan, P; Zhang, Y; Huo, Y; Wang, B; Cheng, Z; Cao, Y; Li, L; Zeng, Y; Lan, L; Lu, Y; Mao, L; Zhang, Z; Chen, C; Wang, Q; Yu, H; Li, J; Zhu, J

doi:10.1007/s00198-026-08262-5

Denosumab biosimilar HLX14 versus EU-denosumab in postmenopausal women at high fracture risk: a randomized, double-blind, multicenter phase 3 trial

Osteoporos IntPublished 4 Nov 2026randomized, double-blind, multicenter, parallel-controlled phase 3 study

Primary result · Co-primary: percent change from baseline in lumbar spine BMD (LS-BMD)ResultAdjusted mean difference 0.23% 90% CI −0.36% to 0.83%

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Authors' conclusion

The findings from this phase 3 study support biosimilarity between HLX14 and denosumab.

Study context

Population: Elderly female subjects with osteoporosis at high risk of fracture, 40 hospitals in Chinainitially enrolled · HLX14 256 · EU-denosumab 258
Participants: 514 subjects

Comparison: HLX14 vs European Union-sourced denosumab
Primary endpoint: Co-primary: percent change from baseline in lumbar spine BMD (LS-BMD)
Follow-up: Week 52

Methodological detailsequivalence, re-randomization at Week 52

Equivalence
Re-randomization at Week 52

Primary result

As reported in the abstract

Adjusted mean difference

0.23%

90% CI −0.36% to 0.83%

Change by group

HLX14

6.10%

EU-denosumab

5.90%

HLX14vs EU-denosumab

adjusted mean difference 0.23% (90% CI −0.36% to 0.83%)

Secondary outcomes

Outcome	← Lower with HLX14 ←→ Higher with HLX14 →	Geometric mean ratio (90% CI)
Co-primary: AUEC0-26W of percent change of serum type I collagen C-telopeptide · baseline to Week 26HLX14vs EU-denosumabPharmacodynamic equivalence shown	0.512	1.01 (0.99–1.04)
	0.512Geometric mean ratio (log scale)

Co-primary: AUEC0-26W of percent change of serum type I collagen C-telopeptide: 95% CI: 0.98, 1.05; within equivalence margins of 0.8 to 1.25

Secondary efficacy endpoints

Supported the equivalence between HLX14 and EU-denosumab

Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.

Original publication

Denosumab biosimilar HLX14 versus EU-denosumab in postmenopausal women at high fracture risk: a randomized, double-blind, multicenter phase 3 trial. Osteoporos Int. Published 4 November 2026. doi:10.1007/s00198-026-08262-5

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