Population PK Modeling of Denosumab Biosimilar MB09 and Reference Denosumab to Establish PK Similarity.

ABSTRACT: Background/Objectives: MB09 is a denosumab biosimilar to the reference products (RPs) Xgeva and Prolia. A population pharmacokinetic (popPK) meta-analysis was conducted to characterize the denosumab PK profile and to support MB09 biosimilarity. Methods: Pooled denosumab PK data from one phase I study [255 healthy adult men receiving a single 35 mg subcutaneous (SC) dose] and one phase III study (555 postmenopausal women with osteoporosis receiving two 60 mg SC doses, one every six months) were used. A one-compartment model with first-order absorption and elimination and parallel non-linear saturable clearance was used. Body weight was included on clearance as a structural covariate and treatment was tested as a covariate on all PK parameters. PK biosimilarity was assessed at

SUBMITTER: Sanchez-Vidaurre S 

PROVIDER: S-EPMC12473923 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature