Blog Big Molecule Watch January 25, 2022

FDA Completes Safety Review of Lannett’s IND for Insulin Glargine Biosimilar

Lannett Company, Inc. (“Lannett”) announced Friday that the FDA has completed its safety review of Lannett’s Investigational New Drug application for Lannett’s insulin glargine biosimilar, a product Lannett is co-developing with its strategic alliance partners within the HEC group of companies, and has concluded that the company may proceed with the proposed clinical investigation.  According to the press release, Lannett anticipates commencing the pivotal trial by March 2022 and completing it by early 2023.  Tim Crew, the chief executive officer of Lannett said, “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.”  According to Crew, the clinical trial will be conducted in South Africa.

The post FDA Completes Safety Review of Lannett’s IND for Insulin Glargine Biosimilar appeared first on Big Molecule Watch.