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Viatris Wins Landmark First US Interchangeability Designation For Semglee

Allows Pharmacy Substitution For Insulin Glargine Biosimilar Rival To Lantus

 
• By Dave Wallace

Viatris has revealed its commercial strategy for its Semglee insulin glargine biosimilar in the US after winning a landmark first designation of interchangeability for the product from the FDA that will allow pharmacy-level substitution with a year of exclusivity.

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Viatris’ Semglee will now be able to be substituted for Lantus • Source: Alamy

Viatris has broken new ground in the US biosimilars market after winning a landmark first interchangeability designation from the US Food and Drug Administration for the firm’s Semglee (insulin glargine-yfgn) biosimilar to Sanofi’s Lantus blockbuster.

The interchangeability designation – a US-specific separate standard to biosimilarity – potentially offers a significant commercial advantage. It will allow...

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