A comparison of asparaginase activity in generic formulations of <i>E.coli</i> derived L‐ asparaginase: In‐vitro study and retrospective analysis of asparaginase monitoring in pediatric patients with leukemia

Abstract

Generic formulations had lower asparaginase activity which raises serious clinical concerns regarding their quality. Until stringent regulatory enforcement improves the quality of these generics, dose adaptive strategies coupled with therapeutic drug monitoring need to be considered.