Lannett On Track To Launch Insulin Glargine By 2023
Company Expects Pivotal Trial For Lantus Biosimilar To Start In 2022
After receiving feedback from the FDA, Lannett has announced that it is on track to submit an investigational new drug application for its insulin glargine candidate to the agency later in 2021. Following this, the company plans to file a biologics license application in 2022 and launch the product in 2023.
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Lannett has delivered on its promise of kicking off a pivotal clinical trial for its proposed interchangeable biosimilar rival to Lantus by the end of March, as it eyes a 2023 filing and 2024 launch in the US for the insulin glargine product on which it has partnered with HEC.
Lannett says it is ready to kick off the pivotal clinical trial for the biosimilar insulin glargine candidate it is developing with HEC, after the US FDA completed the safety review of the product’s investigational new drug application.
As Lannett announced the submission of an IND with the FDA for the proposed insulin glargine biosimilar rival to Lantus that it is developing with HEC, the company set out key development and commercialization milestones for the product in 2022, 2023 and 2024.