Discussion on similarity assessment of denosumab biosimilars
KAN Hong-jin
WEI Wei
Abstract：With the expiration of the patent of denosumab(Prolia®/Xgeva®)and its marketing in China,the number of denosumab biosimilars developed by domestic biological enterprises according to the path of biosimilars is gradually increasing.This paper reviews the domestic and foreign registration and research status of the original drug and biosimilars,clarifies the challenges and technical requirements in the similarity evaluation of denosumab,analyzes and discusses the common problems in the pharmaceutical evaluation of denosumab biosimilars in combination with the review practice,in order to provide a basis for the pharmaceutical development and evaluation of denosumab biosimilars.
Keywords：denosumabbiosimilarsimilarity assessment
Publication Date：2023-12-31
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2477-2482 )