Lannett Company announced that subject dosing has been completed in the pivotal clinical trial of biosimilar insulin glargine, a product the company is co-developing with its strategic alliance partners within the HEC Group of companies (HEC). No serious adverse events have thus far been reported.
"We achieved the subject enrollment goal to meet our statistical endpoints," said Tim Crew, chief executive officer of Lannett. "Dosing of all subjects has now been completed in the healthy volunteer pharmacokinetics (PK) and pharmacodynamics (PD) study of Lannett/HEC's biosimilar insulin glargine. We continue to expect top-line data and analytics to be available toward the end of this calendar year. We then anticipate filing the Biologics License Application (BLA) for a biosimilar and interchangeable insulin glargine to Sanofi's Lantus® Solostar in the Spring of 2023 and potentially launching the product in the first half of 2024."
Biosimilar insulin glargine is the most significant opportunity in the company's current pipeline. Recent estimated U.S. sales of long acting insulin glargine are approximately $10 billion annually, according to IQVIA, although manufacturer reported sales are less.
Lantus® is a registered trademark of Sanofi S.A.
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