PHILADELPHIA, June 11, 2020 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today said that representatives from the company spoke with and received guidance from the U.S. Food and Drug Administration (FDA) on the clinical advancement program of its biosimilar insulin glargine partnered product candidate. Insulin glargine is a long-acting insulin used to treat adults with Type 2 diabetes, as well as adults and pediatric patients with Type 1 diabetes, for the control of high blood sugar. Total U.S. sales of the glargine related products, according to IQVIA, were approximately $9.5 billion for the 12 months ending April 2020, although actual biosimilar market values are expected to be lower.
"At the Biosimilar Biological Product Development (BPD) Type II meeting held earlier this week the FDA provided positive feedback on the clinical and CMC (Chemistry, Manufacturing and Controls) advancement of our biosimilar insulin glargine that was consistent with our expectations," said Tim Crew, chief executive officer of Lannett. "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 calendar year 2022. We will work with our strategic partner to complete all the necessary development activity, including human clinical trials, in accordance with FDA's guidance."
Crew added, "Biosimilar insulin glargine represents a significant opportunity for Lannett, given the notably large addressable market. Moreover, we believe only a relatively small number of competitors have the technical expertise and requisite resources to develop and manufacture such a complex product."
The company previously announced positive results from the first human study evaluating insulin glargine that Lannett is developing with its strategic alliance partners within the HEC Group of companies (HEC). The trial confirmed that the Lannett/HEC biosimilar insulin glargine was biosimilar to US-approved Lantus® (the reference biologic) in terms of meeting all pharmacokinetics (PK) and pharmacodynamics (PD) safety endpoints in the study.
Lantus® is a registered trademark of Sanofi S.A.
About Lannett Company, Inc.: Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications. For more information, visit the company's website at www.lannett.com.
This news release contains certain statements of a forward-looking nature relating to future events or future business performance. Any such statements, including, but not limited to, advancing the development of biosimilar insulin glargine, as well as timing and outcome of FDA approval and successfully commercializing the product, whether expressed or implied, are subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the difficulty in predicting the timing or outcome of FDA or other regulatory approvals or actions, the ability to successfully commercialize products upon approval, including acquired products, and Lannett's estimated or anticipated future financial results, future inventory levels, future competition or pricing, future levels of operating expenses, product development efforts or performance, and other risk factors discussed in the company's Form 10-K and other documents filed with the Securities and Exchange Commission from time to time. These forward-looking statements represent the company's judgment as of the date of this news release. The company disclaims any intent or obligation to update these forward-looking statements.