Pharmacokinetics and pharmacodynamics of the denosumab biosimilar FKS518 and reference denosumab in healthy subjects: the Lumiade-1 study.

ABSTRACT: Denosumab is a fully human monoclonal antibody that increases BMD, inhibits bone resorption and reduces fracture risk. This double-blind, randomized, parallel group study aimed to demonstrate the pharmacokinetic (PK) equivalence and compare the pharmacodynamic (PD), safety and immunogenicity profiles of the proposed denosumab biosimilar FKS518 vs the originator (reference) denosumab. Healthy males (28-55 yr) were randomized to a single 60 mg s.c. injection of FKS518 or the reference denosumab (Prolia) and were followed for 40 wk after drug injection. The primary endpoints were area under the concentration-time curve (AUC) from time zero to infinity, AUC from time zero to the last quantifiable concentration, and maximum observed serum concentration. A total of 213 subjects were injected. Ph

SUBMITTER: Dryja A 

PROVIDER: S-EPMC12766911 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature