Lannett Initiates Human Clinical Trials On Insulin Glargine Biosimilar

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.