Lannett Prepares For Insulin Glargine Trial

Pivotal Clinical Trial For Biosimilar Lantus Rival Expected To Begin In March 2022

Lannett says it is ready to kick off the pivotal clinical trial for the biosimilar insulin glargine candidate it is developing with HEC, after the US FDA completed the safety review of the product’s investigational new drug application.

March 2022 calendar
Lannett will begin its pivotal trial in March 2022 • Source: Sergei Babenko / Alamy Stock Photo

Lannett says it expects to begin by March 2022 the pivotal clinical trial for the biosimilar rival to Lantus (insulin glargine) that it is developing with the HEC group, after the US Food and Drug Administration completed the safety review of the product’s investigational new drug application and concluded that the company can proceed with the proposed clinical investigation.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Biosimilars

BGMA Becomes Medicines UK

 
• By 

The UK generics and biosimilars industry will now be represented by Medicines UK, the new name for the former British Generic Manufacturers Association.

J&J Denied Injunction Over Private-Label Ustekinumab In US

 
• By 

Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.

What’s Next? Five Things To Look Out For In May

 
• By 

Generics Bulletin previews the most noteworthy and anticipated events for May 2025.

Sandoz And Henlius Join Forces With $300m Ipilimumab Deal

 
• By 

Sandoz has struck a deal worth up to $301m with Henlius giving it rights to a proposed ipilimumab biosimilar to Yervoy in countries across the world.

More from Products

Sandoz And Henlius Join Forces With $300m Ipilimumab Deal

 
• By 

Sandoz has struck a deal worth up to $301m with Henlius giving it rights to a proposed ipilimumab biosimilar to Yervoy in countries across the world.

Discounted Ustekinumab Biosimilars Further Dent J&J’s Q1 Stelara Sales

 

With discounts reaching up to 90%, ustekinumab biosimilars have eroded originator Stelara’s sales as expected. In its latest quarterly biosimilar market report, Samsung Bioepis also analyzed the latest regulatory steps to streamline biosimilar development.

Iconovo Slims Down As It Focuses On Commercialization

 
• By 

As its need for development resources declines, Iconovo is cutting staff to save money as it moves to the commercialization stage for its portfolio of off-patent inhaled products.