Population pharmacokinetics/pharmacodynamics analysis confirming biosimilarity of SB16 to reference denosumab.

ABSTRACT:

Background

This analysis aims to evaluate the population pharmacokinetics (PK) and pharmacodynamics (PD) of denosumab and applied a population PK/PD approach to assess the biosimilarity of SB16 in comparison to reference product, denosumab (DEN).

Methods

Pooled serum concentrations data for SB16 and DEN from male healthy volunteers (HV) in the Phase I and from postmenopausal women with osteoporosis (PMO) Phase III studies, along with lumbar spine bone mineral density (BMD) data from Phase III study, were analyzed using a nonlinear mixed effects population PK/PD sequential modeling approach. The effects of key patient variables on PK/PD parameters were assessed. Treatment effects on clearance (CL) were retained in the model, regardless of statistical significance, to enable c

SUBMITTER: Choi S 

PROVIDER: S-EPMC12403037 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature