Lannett gets FDA nod for clinical trial of biosimilar insulin glargine
Lannett Company has been given clearance from the US Food and Drug Administration (FDA) to proceed with a clinical trial of biosimilar insulin glargine.
The FDA clearance follows the completion of the regulator’s safety review of the investigational new drug (IND) application for the biosimilar.
Lannett is co-developing biosimilar insulin glargine with its alliance partners within the HEC Group of companies.
The US-based pharma company expects to begin a pivotal clinical trial by March 2022 with completion likely to be by early 2023.
Tim Crew — Lannett CEO said: “We are on track to initiate the dosing of subjects later this quarter.
“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.”
The clinical trial for biosimilar insulin glargine will be carried out in South Africa at the same site and use the same clinical design as the previously concluded first human volunteer pilot study.
Lannett said that the pivotal trial will be undertaken using the proposed final to-be-marketed formulation of the Lannett/HEC biosimilar insulin glargine.