Comprehensive Physico-chemical and Functional Similarity Assessment Study of RGB-14-P and RGB-14-X Drug Products as Proposed Biosimilars to Denosumab Reference Products.

ABSTRACT:

Background and objective

Denosumab is a fully human monoclonal antibody (IgG2) k subclass that targets and binds with high affinity and specificity to receptor activator of nuclear factor-κB ligand (RANKL). Gedeon Richter's denosumab RGB-14-P and RGB-14-X are proposed biosimilar drug products to the reference medicinal products Prolia^® and Xgeva^® (marketing authorisation holder: Amgen Europe B.V. in the European Union [EU] and Amgen Inc. in USA, respectively). The present study demonstrates the structural, physico-chemical and functional similarity between RGB-14 and reference drug products marketed in the EU and US.

Methods

Using an extensive, state-of-the-art analytical and functional panel of 38 methods ensured the comprehensive characterisation of t

SUBMITTER: Garai AS 

PROVIDER: S-EPMC12354141 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature