Lannett Receives the US FDA’s Feedback for Development of Biosimilar Insulin Glargine

Shots:

• The US FDA provide feedback on the pivotal trial protocol and statistical analysis plan (SAP) for the development program of biosimilar insulin glargine candidate, which the company plan to launch in 2023
• The US FDA has requested Lannett to submit a protocol for the pivotal trial for review before IND submission. Lannett plans to initiate a pivotal trial for the development of biosimilar insulin glargine candidate in early 2022 and intends to file BLA in 2022
• The study indicates that the Lannett/HEC insulin glargine product was similar to the US approved Lantus (the reference biologic) by meeting all PK and PD safety endpoints in the study

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