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Lannett Says FDA Completed Review Of IND Application For Biosimilar Insulin Glargine

Drug maker Lannett Company, Inc. (LCI), said on Friday that the U.S. Food and Drug Administration or FDA has notified the company that it may proceed with its the proposed clinical trials on biosimilar insulin glargine.

The federal agency conducted a safety review of the Investigational New Drug (IND) application filed by Lannett to allow the firm to move ahead with its clinical investigations on biosimilar insulin glargine.

Biosimilar insulin glargine, a product the company is co-developing with its partners within the HEC Group of companies (HEC).

The company said it anticipates the pivotal clinical trial of the product to commence by March and be completed by early 2023.

Tim Crew, CEO of Lannett, commented: "…If the trial is successful, we would anticipate filing the Biologics License Application (BLA) in early 2023 and, if then approved, potentially launching the product by early 2024."

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