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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...

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