Tony Hagen is senior managing editor for The Center for Biosimilars®.
Lannett modifies a pivotal trial design to ensure a smoother ride through the FDA product review.
Lannett, a Philadelphia-based pharmaceutical company, said it was on track to conduct a pivotal trial—meaning critical to FDA approval—of its biosimilar insulin glargine candidate, which it hopes to launch in 2023. The company said it intends to file an investigational new drug application to the FDA later this year, which would allow it to initiate the trial early in 2022.
Glargine is a long-acting insulin. The biosimilar candidate would reference Lantus, produced by Sanofi. There are no FDA-approved insulin biosimilars on the market. Lannett is primarily a generics producer and distributor. The insulin glargine project is being handled in partnership with the HEC Group of Companies.
Lannett said it recently had a Biosimilar Biological Product Development Type 2 meeting with the FDA and followed up by submitting a protocol for the trial along with a statistical analysis plan for product development. Lannett said it has received feedback on that submission and incorporated the guidance into the pivotal trial design.
Modifications made to the trial design to comply with FDA requirements included type and size of the trial and primary and secondary end points. “The proposed pivotal trial, albeit with a larger number of proposed participants, is similar to the previously completed first human volunteer pilot study, which indicated that the Lannett/HEC insulin glargine product was biosimilar to US-approved Lantus in terms of meeting all pharmacokinetics and pharmacodynamics safety end points in the study,” Lannett said.
Short-Acting Insulin Biosimilar
In February 2021, Lannett stated that it was also working with HEC to bring a short-acting insulin aspart biosimilar to market. Insulin aspart is usually taken just before meals to control blood sugar levels in adults with type 1 and type 2 diabetes. The company said that in partnering for development of this agent, it was taking aim at a $6 billion market that includes NovoLog, a Novo Nordisk product. The long-acting market is somewhat larger: $10 billion, according to IQVIA.
“We believe the clinical program for biosimilar insulin aspart will be quite similar to the clinical program for our biosimilar insulin glargine product, which is around 1 year further along in development," Tim Crew, CEO of Lannett, said in a statement.