Generics
Lannett completes participant dosing in biosimilar insulin glargine pivotal clinical trial
1 September 2022 -

Lannett Company, Inc. (NYSE: LCI), a US-based company that develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications, announced on Wednesday that it has completed the dosing of participants in the pivotal clinical trial of biosimilar insulin glargine.

The study has not reported any serious adverse events so far.

The company is co-developing the product with its strategic alliance partners within the HEC Group of companies (HEC).

Tim Crew, Lannett chief executive officer, said, 'We achieved the subject enrolment goal to meet our statistical endpoints. Dosing of all subjects has now been completed in the healthy volunteer pharmacokinetics (PK) and pharmacodynamics (PD) study of Lannett/HEC's biosimilar insulin glargine. We continue to expect top-line data and analytics to be available toward the end of this calendar year. We then anticipate filing the Biologics License Application (BLA) for a biosimilar and interchangeable insulin glargine to Sanofi's Lantus Solostar in the Spring of 2023 and potentially launching the product in the first half of 2024.'

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