Lannett 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
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