Physicochemical and functional characterization of MYL-1501D, a proposed biosimilar to insulin glargine.

ABSTRACT: Insulin glargine is a long-acting analogue of human insulin that has been used to manage hyperglycemia in patients with diabetes mellitus (DM) for nearly 20 years. Insulin glargine has a relatively constant concentration-time profile that mimics basal levels of insulin and allows for once-daily administration. MYL-1501D is a biosimilar insulin glargine designed to offer greater access of insulin glargine to patients, with comparable efficacy and safety to the marketed reference product. We conducted a comprehensive panel of studies based on a formal analysis of critical quality attributes to characterize the structural and functional properties of MYL-1501D and reference insulin glargine products available in the United States and European Union. MYL-1501D was comprehensively shown to have

SUBMITTER: Goyal P 

PROVIDER: S-EPMC8208551 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature