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# Lannett Gets FDA Meeting on Proposed Insulin Biosimilar
- URL: https://www.fdaweb.com/lannett-gets-fda-meeting-on-proposed-insulin-biosimilar/
- Published: 2020-04-08T12:00:00.000Z
- Updated: 2026-09-14T16:10:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146522

Lannett says FDA has granted it a 6/9 Biosimilar Biological Product Development Type 2 meeting to plan “next steps“ for the clinical development of its biosimilar insulin glargine product candidate for use in treating adults with Type 2 diabetes, as well as adults and pediatric patients with Type 1 diabetes. “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 says.

The company previously announced positive results from a human study evaluating insulin glargine that Lannett is developing with its strategic alliance partners within the HEC Group of companies. Lannet says the trial confirmed that the proposed biosimilar matches the FDA-approved reference biologic (Sanofi’s Lantus) in terms of pharmacokinetics and pharmacodynamics safety. The study, it says, met all primary endpoints.