Lannett Up After FDA Gives OK For Biosimilar Insulin Trial
January 21 2022 - 7:59AM
Dow Jones News
By Michael Dabaie
Lannett Co. Inc. shares rose 4.5% to $1.62 premarket after the
generic pharmaceutical company said the U.S. Food and Drug
Administration said it could proceed with a proposed clinical
investigation for biosimilar insulin glargine.
The company said it expects the pivotal clinical trial to start
by March and be completed by early 2023.
If the trial is successful, the company said it anticipates
filing the biologics license application in early 2023 and
potentially launching the product by early 2024.
Glargine is a product the company is co-developing with its
strategic alliance partners within the HEC Group of companies.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
January 21, 2022 07:44 ET (12:44 GMT)
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