- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Lannett Will Discuss Insulin Glargine Application With FDA
Longtime generics manufacturer Lannett is moving an insulin glargine biosimilar development plan forward and announced an upcoming meeting with the FDA. The agent would compete with the reference product Lantus.
Longtime generic drug manufacturer Lannett said it would meet with the FDA June 9, 2020, to plan the next steps for clinical advancement of its planned insulin glargine biosimilar. Insulin glargine is a long-acting insulin used to treat adults with type 2 diabetes and adults and pediatric patients with type 1 diabetes.
Under a March 23, 2020, change in the approval pathway for insulin products, insulin glargine is now considered a biologic and must be reviewed under section 351 of the Public Health Service Act. Lannett, of Philadelphia, Pennsylvania, is developing the insulin product in a partnership with the HEC Group of companies.
Tim Crew, chief executive officer of Lannett, said the meeting with the FDA is expected to result in specific guidance that will clarify the requirements for a successful biologics license application.
"We expect our discussion with the FDA to include the design and endpoint of any additional human studies required for filing a Biologics License Application (BLA) and approval of insulin glargine as a biosimilar," he said.
In December 2019, Lannett announced positive results from the first human study evaluating insulin glargine. The company said that in terms of pharmacokinetics and pharmacodynamics, the trial confirmed that the Lannett/HEC biosimilar insulin glargine is equivalent to the reference product Lantus. Lannett said the study met all primary end points.
"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," Crew said at that time.
Kristin Arnold, PhD, Lannett’s vice president of research and development, said the biosimilar insulin candidate product was safe and well tolerated, with no serious adverse events or serious drug reactions observed during the study.
Lannett, founded in 1942, develops, manufactures, packages, markets, and distributes generic pharmaceutical products for a wide range of medical indications.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
The Trump Administration’s Drug Price Actions and Why US Prices Are Already Sky-High
May 17th 2025While the Trump administration’s latest executive order touts sweeping drug price cuts through international benchmarking, the broader pharmaceutical pricing crisis in the US reveals a far more complex web of development costs, profit incentives, and absent price controls—raising the question of whether any single policy, including potential drug tariffs, can truly untangle it.
