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# Lannett Sees Clear Path for Insulin Glargine Biosimilar
- URL: https://www.fdaweb.com/lannett-sees-clear-path-for-insulin-glargine-biosimilar/
- Published: 2020-06-11T12:00:00.000Z
- Updated: 2026-09-14T16:17:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146985

Following a meeting with FDA staff on the Lannett clinical advancement program for its biosimilar insulin glargine product candidate, the company [says](https://www.dailyamerican.com/news/state/lannett-provides-update-on-clinical-advancement-of-biosimilar-insulin-glargine-following-fda-meeting/article%5Fe63f784f-4bf9-5c26-be24-13637ed4b8e5.html?ref=fdaweb.com) it received positive feedback on the clinical and CMC (chemistry, manufacturing, and controls) advancement of its product. “Our path forward is clear with regard to what is expected in the planned 351(k) biosimilar application, which we anticipate will be filed in the calendar year 2022,” said Lannett CEO **Tim Crew**. “We will work with our strategic partner to complete all the necessary development activity, including human clinical trials, in accordance with FDA’s guidance.”