Lannett has commenced the dosing of the first subject in the pivotal clinical trial of biosimilar insulin glargine.
The product is being jointly developed by the company along with its strategic alliance partners within the HEC Group of companies.
Lannett anticipates reporting topline data from the trial later this year.
The pivotal trial is being carried out in South Africa at the same study centre and with the same overall clinical design of a priorly concluded first-in-human pilot study.
The first study was reviewed by the US Food and Drug Administration (FDA), which recommended that the Lannett/HEC insulin glargine product would be biosimilar to Sanofi’s Lantus on meeting the pharmacokinetics (PK) and pharmacodynamics (PD) endpoints of the trial.
Lantus is the reference biologic of the Lannett biosimilar and has also obtained approval for use in the US.
Clinical material manufactured at a commercial scale in a new insulin facility will be used for the pivotal trial.
Lannett CEO Tim Crew said: “Biosimilar insulin glargine is by far the biggest and most important opportunity in our pipeline, and initiating the pivotal clinical trial is a major step forward in bringing a high quality, more affordable insulin to the millions of patients in the US with diabetes.
“If successful, we anticipate filing the Biologics License Application (BLA) for a biosimilar and interchangeable insulin glargine to Sanofi’s Lantus Solostar in early 2023 and potentially launching the product in the first half of 2024.”
In January this year, the FDA concluded the safety review of the Investigational New Drug (IND) application submitted by the company for the biosimilar and provided clearance to launch the trial.