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

Ref: Prnewswire | Image: Mint