LCI - Lannett begins trial for biosimilar of Sanofi's insulin glargine Lantus

Lannett (NYSE:LCI) said it began a pivotal clinical trial of biosimilar insulin glargine, Sanofi's (SNY) Lantus. The company is co-developing the product with its strategic alliance partners within the HEC Group of companies (HEC). Lannett said a prior first study, which the FDA reviewed, suggested that the Lannett/HEC insulin glargine product would be biosimilar to the U.S.-approved Lantus in terms of meeting study's pharmacokinetics and pharmacodynamics goals. "The first subject in the pivotal trial has been dosed and we believe top line results of the study will be available toward the end of this calendar year," said Tim Crew, CEO Lannett. Crew added that the company expects to file an application for the biosimilar  insulin glargine in early 2023 and potentially launching the product in H1 2024.

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Lannett begins trial for biosimilar of Sanofi's insulin glargine Lantus