Tony Hagen is senior managing editor for The Center for Biosimilars®.
Longtime generics manufacturer Lannett is moving an insulin glargine biosimilar development plan forward and announced an upcoming meeting with the FDA. The agent would compete with the reference product Lantus.
Longtime generic drug manufacturer Lannett said it would meet with the FDA June 9, 2020, to plan the next steps for clinical advancement of its planned insulin glargine biosimilar. Insulin glargine is a long-acting insulin used to treat adults with type 2 diabetes and adults and pediatric patients with type 1 diabetes.
Under a March 23, 2020, change in the approval pathway for insulin products, insulin glargine is now considered a biologic and must be reviewed under section 351 of the Public Health Service Act. Lannett, of Philadelphia, Pennsylvania, is developing the insulin product in a partnership with the HEC Group of companies.
Tim Crew, chief executive officer of Lannett, said the meeting with the FDA is expected to result in specific guidance that will clarify the requirements for a successful biologics license application.
"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," he said.
In December 2019, Lannett announced positive results from the first human study evaluating insulin glargine. The company said that in terms of pharmacokinetics and pharmacodynamics, the trial confirmed that the Lannett/HEC biosimilar insulin glargine is equivalent to the reference product Lantus. Lannett said the study met all primary end points.
"With the positive data from this human clinical trial, combined with the earlier comparative analytical assessment and animal studies, we are building certainty around our development program," Crew said at that time.
Kristin Arnold, PhD, Lannett’s vice president of research and development, said the biosimilar insulin candidate product was safe and well tolerated, with no serious adverse events or serious drug reactions observed during the study.
Lannett, founded in 1942, develops, manufactures, packages, markets, and distributes generic pharmaceutical products for a wide range of medical indications.