LUMIADE 3: Therapeutic Equivalence of Denosumab Biosimilar FKS518 to Reference Product in Postmenopausal Osteoporosis
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.
Authors
- Serge Ferrari (ORCID: https://orcid.org/0000-0002-1372-4417)
- Ivo Valter
- Wojciech Pluskiewicz (ORCID: https://orcid.org/0000-0003-1839-6560)
- Ersilia Varone (ORCID: https://orcid.org/0000-0002-1537-3358)
- Corinne Petit-Frère
- Peter Szeles
- Jerzy Supronik
- E. Krecipro-Nizinska
Institutions
- Wrocław University of Science and Technology (PL)
- Medical University of Silesia (PL)
- Niepubliczna Wyższa Szkoła Medyczna (PL)
- Centro Científico Tecnológico - Nordeste (AR)
- University Hospital of Geneva (CH)
- Anna Needs Neuroblastoma Answers (US)
- Geneva College (US)
- Fresenius Kabi (Czechia) (CZ)
Publication Details
- Journal
- Journal of the Endocrine Society
- Published
- 2025-10-21
- DOI
- https://doi.org/10.1210/jendso/bvaf164
- Citations
- 1
- Primary Topic
- Biosimilars and Bioanalytical Methods
- Type
- article
- Field-Weighted Citation Impact
- 0.80