Lannett is one step closer to launching biosimilar insulin glargine.
Recently, the company completed subject dosing in the pivotal clinical trial of biosimilar insulin glargine, a product being co-developed with partners within the HEC Group of companies.
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No serious adverse events have thus far been reported, Lannett said.
"We achieved the subject enrollment goal to meet our statistical endpoints," said Tim Crew, CEO of Lannett. "Dosing of all subjects has now been completed in the healthy volunteer pharmacokinetics and pharmacodynamics 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 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."
Recent estimated U.S. sales of long-acting insulin glargine are approximately $10 billion annually, according to IQVIA, although manufacturers reported sales are less.