Comparative physicochemical and biological characterization of the similar imiglucerase product Glurazyme® and the originator product Cerezyme®

Abstract

A biosimilar considered as a biomolecule medicinal product that is comparable to a reference medicinal product in terms of the structural, functional, biological, and clinical attributes. Glurazyme® was developed as a biosimilar to Cerezyme® (imiglucerase) and was approved in CIS countries (Russian Federation, Belarus, Kazakhstan) and recently Algeria for the treatment of type 1 and type 3 Gaucher disease. The quality assessment of Glurazyme® was performed in accordance with the Rules for the Study of Biological Medicines of the Eurasian Economic Union harmonized with the ICH comparability guideline and the biosimilar guidelines of the European Medicines Agency and Food and Drug Administration. Extensive side-by-side comparison was employed with state-of-the-art and orthogonal assays designed to interrogate all expected physicochemical and biological activities, including those known to affect the mechanisms of action for imiglucerase. Similarity evaluation was performed on the basis of tolerance intervals determined from about 10 lots of commercial Cerezyme®. Mainly three discrepancies of quality attributes were established concerning oxidized and deamidated forms as well as phosphorylated oligomannose N-glycans reflecting the difference between cultivation and down-stream processes of both medicinal products. Nevertheless, all of them possess a little or no influence on safety and efficacy.