Common pharmaceutical issues and review considerations for biologics license applications of antibody products
ZHAO Jing
WEI Wei
HE Wu
Abstract：With the increase in the number of biologics license applications(BLAs),common issues in CMC dossier are gradually becoming prominent.This article takes antibody products as an example and proposes the overall considerations for CMC evaluation for biological products'BLA.Based on practical evaluation experience,the common problems in the pharmaceutical research data of such products'BLA are sorted out in four aspects:raw materials,production processes,quality research and quality control,and stability research.Based on the common issues,review recommendations are proposed in order to help applicants improve the quality of their submitting documents,further enhance the efficiency of evaluation,and reduce the delay in listing time caused by supplementary research data.
Keywords：antibodybiologics license applicationCMC researchcommon issuesevaluation consideration
Publication Date：2025-03-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 571-578 )