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

 ­ Ref: PRNewswire | Image: Lannett