Lannett hopes to initiate a pivotal trial of its insulin glargine biosimilar candidate, in anticipation of a launch in 2024.
Lannett, a Philadelphia-based company, has announced the submission of a new drug application for a clinical trial of a potential biosimilar insulin glargine (long acting) product that the company is developing with HEC Group.
“This [investigational new drug] application is a key milestone and brings us one step closer to bringing this critically important and more affordable biosimilar medicine to the large and growing number of patients living with diabetes,” Tim Crew, CEO of Lannett, said in a statement.
Crew said the trial would be pivotal (play a key role in the regulatory approval of the product) and would commence roughly in March 2022. The company hopes to be able to file a biologics license application to the FDA in 2023 and launch by 2024, it said.
The biosimilar product would reference Lantus, produced by Sanofi, and was demonstrated in a volunteer pilot study to have similar pharmacokinetic and pharmacodynamic qualities. The new trial would be conducted in South Africa and has received approval to commence from that country’s Health Products Regulatory Authority.
“The trial site has experience with clinical insulin trials and has been used by other innovator firms for their insulin clinical trials,” Lannett said.
In March 2021, when Lannett first announced intentions to conduct a pivotal trial of its insulin glargine candidate, there were no biosimilar insulins on the US market.
That changed in July 2021 when Semglee, a Biocon Biologics/Viatris product, received FDA approval as the first insulin glargine biosimilar and the first interchangeable biosimilar, meaning pharmacists could substitute it for more-expensive brand products without prescribing physician intervention.