Lannett announced that the U.S. Food and Drug Administration (FDA) has notified the company that they have completed the safety review of the Investigational New Drug (IND) application for biosimilar insulin glargine, a product the company is co-developing with its strategic alliance partners within the HEC Group of companies (HEC), and concluded that the company may proceed with the proposed clinical investigation. The company said it anticipates the pivotal clinical trial to commence by March 2022 and be completed by early 2023.

"We are on track to initiate the dosing of subjects later this quarter," said Tim Crew, chief executive officer of Lannett. "If the trial is successful, we would anticipate filing the Biologics License Application (BLA) in early 2023 and, if then approved, potentially launching the product by early 2024. Biosimilar insulin glargine is a key product in our durable product pipeline; we look forward to bringing this critically important and more affordable biosimilar medicine to the large and growing number of patients living with diabetes."

Crew added, the clinical trial will be conducted in South Africa at the same site and use the same clinical design as the previously completed first human volunteer pilot study. With FDA's review of the IND, the necessary regulatory clearances (both in the U.S. and South Africa) to conduct the study have been received. The pivotal trial will be conducted using the proposed final to-be-marketed formulation of the Lannett/HEC biosimilar insulin glargine.

Lantus is a registered trademark of Sanofi S.A.