Viatris and Biocon’s Semglee (biosimilar, insulin glargine) Receive the US FDA’s Approval as the First Interchangeable Biosimilar for Diabetes

July 29, 2021 Auto Bot approval, Biocon, Biosimilar, Biosimilars, diabetes, FDA, Viatris 0

Shots:

  • The US FDA has approved Semglee (insulin glargine-yfgn injection) as the first interchangeable biosimilar product under the 351(k) regulatory pathways to treat diabetes
  • Semglee will allow pharmacy level substitution for the reference product, Lantus across the US & will be launch before the end of 2021. Biocon is eligible to have exclusivity for 12mos. from the date of commercial launch of the biosimilar
  • Semglee has an identical amino acid sequence to Lantus and has received regulatory approval in 60+ countries globally. The biosimilar marks the third US FDA approved product under Viatris-Biocon collaboration

Click here to read full press release/ article | Ref: Prnewswire | Image: Mint

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