ArticleJournal of the Endocrine Society2025
LUMIADE 3: Therapeutic Equivalence of Denosumab Biosimilar FKS518 to Reference Product in Postmenopausal Osteoporosis.
Article in Journal of the Endocrine Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- LUMIADE 3: Therapeutic Equivalence of Denosumab Biosimilar FKS518 to Reference Product in Postmenopausal Osteoporosis.Journal of the Endocrine Society · 2025Article
- Development and validation of a method for quantitation of CTx-1 for the assessment of biosimilarity of FKS518, a denosumab biosimilar.Bioanalysis · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objectives: To demonstrate therapeutic equivalence of the proposed denosumab biosimilar FKS518 to the originator denosumab (US-licensed Prolia®, reference product), a potent antiresorptive biologic that increases bone mineral density (BMD) and reduces the risk of fractures, in women with postmenopausal osteoporosis. Methods: This 78-week double-blind, controlled, randomized, multicenter, multiple-dose, 2-arm, parallel-group study compared the efficacy (BMD), pharmacodynamic (bone biomarkers), safety, tolerability, and immunogenicity profiles of FKS518 with those of reference denosumab in women with postmenopausal osteoporosis. Primary-percentage change from baseline to 52 weeks in lumbar spine BMD and area under the effect curve from baseline to week 26 of serum C-terminal cross-linking telopeptide of type 1 collagen-and secondary results from the 52-week core treatment period are reported here. Results: Postmenopausal women with osteoporosis were randomized to receive 60 mg of FKS518 (n = 277) or reference denosumab (n = 276) every 26 weeks. Demographics, baseline characteristics and medical history were similar between treatment groups. Therapeutic equivalence of FKS518 and reference denosumab was demonstrated for efficacy and pharmacodynamic characteristics. All sensitivity analyses, supportive estimands, secondary efficacy, and pharmacodynamic endpoint analyses consistently showed similarity between the 2 products. Safety outcomes were consistent with the known safety profile of denosumab and were comparable between FKS518 and reference denosumab. Immunogenicity was infrequently observed and similar between the FKS518 and the reference denosumab groups. Conclusion: This study demonstrated therapeutic equivalence of, and comparable pharmacokinetics, safety, and immunogenicity profiles between FKS518 and reference denosumab, completing the clinical evidence to propose FKS518 as a biosimilar to denosumab.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.