earticle

영어

In order to assess similarity of biotherapeutics, many regulatory agencies recommend a stepwise approach for demonstrating biosimilarity between a proposed biosimilar product and an innovative (reference) biological product. In particular, glycosylation critical quality attributes (gCQA) of biosimilar can significantly affect drug's quality, safety, and efficacy. Additionally, the glycosylation is highly heterogeneous because it is primarily influenced by external conditions such as host cell lines and culture conditions. Thus, assessment of gCQA are necessary for evaluation similarity of biosimilars now commg to market. Here, we discuss the state of the art in analytical technologies to assess biosimilarity regarding glycosylation from regulatory perspective.