Lannett has announced that it will meet with the FDA on June 9, 2020, to “plan next steps for the clinical advancement of” its insulin glargine biosimilar product. According to the press release, “[i]nsulin 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.” In December, Lannett announced positive results from the first human study evaluating its insulin glargine biosimilar.
Lannett CEO Tim Crew stated that Lannett expects the “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.”