Logo

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

Share this
Viatris and Biocon's Semglee (biosimilar- insulin glargine) Receive the US FDA's Approval as the First Interchangeable Biosimilar for Diabetes

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

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

Click here to­ read the full press release 

Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions