Viatris Wins Landmark First US Interchangeability Designation For Semglee

Allows Pharmacy Substitution For Insulin Glargine Biosimilar Rival To Lantus

29 Jul 2021

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.

Interchangeable Swap Icon — 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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