1. Pink Sheet

With Interchangeability Nod, Viatris' Semglee Loses Its Identity

 
• By Sue Sutter

Now approved as an interchangeable biosimilar, US labeling for Viatris’ insulin aspart mirrors that of Sanofi’s Lantus and has shed data from two studies in type 1 and 2 diabetics that showed noninferiority to Sanofi’s Lantus; Viatris appears in line for one year of exclusivity.

The US FDA's first-ever interchangeable designation opens new roads for biosimilars. • Source: Nielsen Hobbs

Viatris Inc.’s Semglee (insulin glargine-yfgn) became the first biosimilar insulin – and the first interchangeable biologic product – in the US with the Food and Drug Administration’s 28 July approval, but lost its labeling on product-specific clinical efficacy and safety data in the process.

The FDA approved Semglee to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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
Start Free Trial

Already a subscriber?

More from Biosimilars

More from Biosimilars & Generics