Lannett Reports the First Patient Dosing in the Pivotal Clinical Trial of Biosimilar Insulin Glargine
Shots:
- The first patient has been dosed in the pivotal clinical trial of biosimilar insulin glargine across South Africa. The biosimilar is being co-developed with its strategic alliance partners within HEC & the results are expected at the end of 2022
- The first study was reviewed by the US FDA which recommended that the Lannett/HEC insulin glargine product would be biosimilar to Sanofi’s Lantus by meeting the PK & PD EPs of the trial. Additionally, clinical material manufactured at a commercial scale in a new insulin facility will be used for the pivotal trial
- If successful, the company will file the BLA in early 2023 & the product is expected to be launched in H1’24, if approved
Ref: PR Newswire | Image: Lannett
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