Lannett Initiates Trial of Its Proposed Insulin Glargine Biosimilar

Generic drug maker Lannett Company has announced the beginning of a clinical trial of its proposed biosimilar insulin glargine referencing Lantus.

The single-center, single-dose, double-blind, randomized, 2-period crossover study in healthy volunteers is designed to compare the pharmacokinetics and pharmacodynamics of the biosimilar to the US-approved insulin glargine. The trial is being conducted in South Africa.

"Initiating a first-in-human clinical trial of our partnered insulin glargine product is a major milestone in the progression of this project," said Tim Crew, chief executive officer of Lannett, in a statement announcing the start of the trial. "We look forward to the clinical advancement of the product as an affordable treatment option, especially with 29 million Americans suffering with type 1 or type 2 diabetes."

Lannett says that the trial is intended to support the submission of an eventual Biologics License Application for the product.

News that Lannett is poised to submit a BLA for its insulin is a notable step as the United States moves toward its 2020 date for transitioning insulins to regulation as biologics.

The Biologics Price Competition and Innovation Act stipulated that a marketing application for a biologic that could have been submitted under section 505 of the Food, Drug and Cosmetic (FD&C) Act must be submitted under section 351 of the Public Health Service (PHS) Act, but some products, like insulin, were allowed a 10-year transition period, which will expire on March 23, 2020.

Starting on that date, approved applications for biologics approved under the FD&C Act will be deemed to be licensed under the PHS Act, and follow-on drugs such as insulin will have to be submitted to the FDA for regulatory review under the biosimilar approval pathway.

Once insulins are regulated as biologics, it will be possible for drug makers to seek interchangeable designations for their products.

Other drug makers seeking a piece of the United States market for insulin glargine include Mylan and Biocon, which received a Complete Response Letter for their product in June 2018. Boehringer Ingelheim and Eli Lilly’s Basaglar, which is both approved and launched in the United States, has captured 34% of the Medicaid market for long-acting insulins and saved Medicaid more than $70 million, according to a recent research letter in JAMA.