Lannett is set to meet with the U.S. Food and Drug Administration (FDA) on June 9, 2020 to plan next steps for the clinical advancement of its biosimilar insulin glargine partnered product candidate. Insulin glargine is a long-acting insulin used to treat adults with Type 2 diabetes, as well as adults and pediatric patients with Type 1 diabetes, for the control of high blood sugar.
"We are pleased that the FDA granted our request for a Biosimilar Biological Product Development (BPD) Type II meeting, in which the FDA will provide specific guidance regarding the ongoing development program of our biosimilar insulin glargine partnered product," said Tim Crew, chief executive officer of Lannett. "We expect our discussion with the FDA to include the design and endpoint of any additional human studies required for filing a Biologics License Application (BLA) and approval of insulin glargine as a biosimilar."
The company previously announced positive results from the first human study evaluating insulin glargine that Lannett is developing with its strategic alliance partners within the HEC Group of companies (HEC). The trial confirmed that the Lannett/HEC biosimilar insulin glargine matches US-approved Lantus® (the reference biologic) in terms of pharmacokinetics (PK) and pharmacodynamics (PD) safety. The study met all primary endpoints.