Lannett Announces Positive Results for Biosimilar Insulin Glargine

Generic drug maker Lannett Company announced positive results from the beginning of a clinical program for its proposed biosimilar insulin glargine referencing Lantus.

The clinical trial was a single center, single-dose, double-blind, randomized, 2-period crossover study comparing the pharmacokinetics and pharmacodynamics of the proposed biosimilar to Lantus after a single subcutaneous dose in 27 healthy male adult human volunteers.

The trial, which met all primary endpoints, also assessed the safety profile of the biosimilar to reference after a single subcutaneous dose. The trial is being conducted in South Africa.

Lannett says that the trial is intended to support the submission of an eventual Biologics License Application (BLA) 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.

The trial was the first clinical study in humans to directly compare the biosimilar insulin glargine to reference insulin glargine.

"With the positive data from this human clinical trial, combined with the earlier comparative analytical assessment and animal studies, we are building certainty around our development program," said Tim Crew, chief executive officer of Lannett, in a statement. "We expect to meet with FDA in the coming months to plan next steps for the clinical advancement of our product, including the design of the biosimilar product development plan."

"In a relatively short amount of time, we have built an impressive and significant amount of data that supports the biosimilarity of our insulin glargine product to the reference drug, US-approved Lantus," added Kristin Arnold, PhD, Lannett's vice president of research and development.

"Importantly, our insulin glargine was safe and well tolerated, and no serious adverse events or serious adverse drug reactions related to the drug were observed during the study. In summary, the phase 1 study, conducted in healthy volunteers, confirmed that biosimilar insulin glargine matches the reference biologic in terms of pharmacokinetics and pharmacodynamics safety,” said Arnold.