–Company Anticipates Biosimilar Application to be Submitted By End of Calendar Year 2022–
PHILADELPHIA, PA, USA I June 11, 2020 I 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.
SOURCE: Lannett Company
Post Views: 24
–Company Anticipates Biosimilar Application to be Submitted By End of Calendar Year 2022–
PHILADELPHIA, PA, USA I June 11, 2020 I 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.
SOURCE: Lannett Company
Post Views: 24
