Longtime generics maker Lannett, of Philadelphia, Pennsylvania, said an FDA meeting this week was positive for its pending insulin glargine biosimilar application.
Lannett, a longtime generics manufacturer, emerged with confidence from a June 9, 2020, FDA meeting on the pending Biologics License Application (BLA) for its insulin glargine biosimilar candidate, which would reference the diabetes control product Lantus.
“At the Biosimilar Biological Product Development Type II meeting held earlier this week, the FDA provided positive feedback on the clinical and [chemistry, manufacturing, and controls] advancement of our biosimilar insulin glargine that was consistent with our expectations,” said Tim Crew, CEO of Lannett, in a statement.
A Significant Market
Insulin glargine is a long-acting agent used to manage high blood sugar in adults with type 2 diabetes and adults and pediatric patients with type 1 diabetes. The market for insulin glargine is dominated by large producers and is estimated at $9.5 billion, which makes it an attractive target for Lannett.
“Biosimilar insulin glargine represents a significant opportunity for Lannett, given the notably large addressable market,” Crew said. “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.”
Lannett, of Philadelphia, Pennsylvania, intends to file under the 351(k) pathway of the Public Health Service (PHS) Act of the Biologics Price Competition and Innovation Act, which provides for the licensure of biosimilars or interchangeables considered highly similar to FDA-approved originator products.
“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 said.
As of March 23, certain protein products, including insulin and insulin analogs, human growth hormone, pancreatic enzymes, and reproductive hormones, will be reviewed under the PHS Act, as opposed to the Federal Food, Dug, and Cosmetic Act, the former pathway to approval for these agents.
Regulators hope that the new pathway will remove barriers that have stymied competition in the past and help lower prices for patients, who have faced high out-of-pocket expenses in the past. Many have had to forgo appropriate or regular treatment with insulin because of affordability issues. Recent policy changes, however, have led to caps on insulin out-of-pocket costs that have lessened the burden for patients.
The goal of the FDA meeting was to discuss the design and end point of human studies required for the BLA. The company in December 2019 announced positive results from a pharmacokinetics and pharmacodynamics study of the biosimilar candidate in healthy male adult volunteers.