Analytical and functional similarity assessment of denosumab biosimilar CMAB807
ZHUANG Huangzhen
GUO Qingcheng
ZHOU Chaoxin
WANG Chenguang
FAN Wenqiang
ZHU Weifan
REN Yule
PAN Zhiyuan
CHEN Yi
GUO Menghui
LIU Tao
JI Lusha
QIAN Weizhu
HOU Sheng
LI Jun
SUN Ziqiao
WANG Xuekun
ZHANG Dapeng
GUO Huaizu
XU Jin
Abstract：Analytical and functional similarity assessments are pivotal to ensuring biosimilars exhibit high consistency with reference products(RPs)in quality,safety,and efficacy.Based on a risk-tiered classifi-cation of critical quality attributes(CQAs),this study systematically evaluated the physicochemical and functional similarity between the Denosumab biosimilar CMAB807 and RPs(Prolia®/Xgeva®)using or-thogonal analytical techniques.Results demonstrated that CMAB807 and RPs share highly comparable pri-mary structures,higher-order structures,purity profiles,and functional activities.Minor differences were observed in specific post-translational modifications,such as C-terminal lysine truncation of the heavy chain.Additionally,CMAB807 exhibited Fc receptor binding profiles consistent with RPs and showed no detectable antibody-dependent cellular cytotoxicity(ADCC)or complement-dependent cytotoxicity(CDC),aligning with the IgG2 subclass characteristics.Through risk-tiered evaluation and comprehensive quality characterization,this study establishes a robust foundation for CMAB807's analytical similarity and supports its clinical comparability investigations.
Keywords：biosimilardenosumabphysicochemical analysisfunctional evaluation
Publication Date：2026-08-25
Online Publishing Date：2026-08-28(First online date of this platform, not the publication date of the document)
Pages：14( 591-602,后插1,封3 )