LCI - Lannett updates on development of biosimilar insulin glargine

Lannett Company (LCI) has announced that it received feedback from the FDA on the development work related to biosimilar insulin glargine.At a Biosimilar Biological Product Development Type 2 meeting held in June 2020, the FDA has requested the company to submit a protocol for the pivotal trial for review before an IND (Investigational New Drug Application) submission.In November 2020, the company has responded by filing the proposed protocol and SAP (statistical analysis plan).In return, the regulator has provided the feedback and comments which the company says have now been incorporated into the pivotal trial design including the type and size of the trial, as well as primary and secondary endpoints.Lannett which is developing biosimilar insulin glargine in partnership with HEC Group of companies expects to submit the IND in late 2021.It also anticipates commencing the pivotal trial in early 2022, filing the BLA later 2022 followed by the product launch in 2023.For

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Lannett updates on development of biosimilar insulin glargine