On June 5, 2019, Lannett Company, Inc. announced they would begin human clinical trials for an insulin glargine biosimilar. According to Lannett’s press release, “[i]nsulin glargine is a long-acting insulin used to regulate the blood sugar of adults with Type 2 Diabetes, as well as adults and pediatric patients with Type 1 diabetes, for the control of high blood sugar.” The clinical trial will compare the Lannett insulin glargine to the Sanofi S.A. US Lantus® reference product in preparation for filing an abbreviated Biologics License Application (aBLA).
Lannett stated that the study is “designed to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of the Lannett/HEC-insulin glargine to US-approved Lantus®, after a single subcutaneous dose in at least 24 healthy male adult human volunteers.” Lannett expects the results of the study in September 2019.