Bioanalysis
Refined ADA testing strategy to overcome sRANKL interference in denosumab/FKS518 immunogenicity assessment.
Anna Lucia Buccarello, Adriano L Soares de Souza, Martin Ullmann, Corinne Petit-Frere
Published: 202510.1080/17576180.2025.2607080
Abstract
BACKGROUND: Fresenius Kabi developed FKS518, a fully human monoclonal antibody biosimilar to denosumab, that inhibits osteoclast activation by targeting the receptor activator of nuclear factor kappa-Β ligand (RANKL). RANKL exists as a trimeric solub…
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