Lannett Developing Biosimilar Insulin Glargine with HEC Group Set to Launch in 2024
As of April 4, 2023, Lannett Company, Inc. is currently in the process of developing a biosimilar insulin glargine product in partnership with the HEC Group of companies. This long-acting insulin is set to reference Lantus, which is produced by Sanofi. Despite primarily being a generics producer and distributor, Lannett has high hopes for their biosimilar insulin glargine candidate, which is expected to launch in 2023.
Lannett recently received feedback from the U.S. Food and Drug Administration (FDA) regarding the pivotal trial protocol and statistical analysis plan for the development program. In order to ensure the success of their biosimilar insulin glargine partnered product candidate, Lannett spoke with and received guidance from the FDA on the clinical advancement program. The company intends to file an investigational new drug application to the FDA later this year, which would allow them to initiate the trial early in 2022.
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