General considerations for the development and similarity evaluation of dulaglutide biosimilars
HU Ying-ying
CHENG Su-yuan
Abstract：Dulaglutide,a long-acting GLP-1 receptor agonist,has become one of the hotspots in the field of biosimilar drugs.However,as a fusion protein,its inherent structural instability poses a challenge.Modifications or degradation of its GLP-1 functional domain can significantly impact biological activity,making the assessment of pharmaceutical similarity particularly difficult.This article summarizes recent advances,by integrating foreign assessment reports,scientific literature,and regulatory review experiences,outlines fundamental considerations for its pharmaceutical development and evaluation,aiming to facilitate the development of such products.
Keywords：dulaglutidebiosimilarresearch progressquality similarityquality control
Publication Date：2025-12-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 2639-2645 )