Lannett to Submit Biosimilar Application to the US FDA for its Insulin Glargine by the End of 2022

 Lannett to Submit Biosimilar Application to the US FDA for its Insulin Glargine by the End of 2022

Lannet to Submit Biosimilar Application to the US FDA for its Insulin Glargine by the End of 2022

Shots:

  • Lannett has provided an update on the clinical advancement of its biosimilar Insulin glargine. Following FDA meeting, Lannett has received FDA’s positive feedback on the clinical and CMC advancement of its biosimilar insulin glargine
  • The company anticipates the filing of 351(k) biosimilar application for its biosimilar insulin glargine candidate by the end of 2022
  • Lannett/HEC’s insulin glargine is a biosimilar to Sanofi’s Lantus (the reference biologic) and met its PK/PD safety endpoints in its study

Click here to read full press release/ article | Ref: PRNewswire | Image: Lannett

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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