Big Molecule Watch
March 26, 2021

Lannett Receives FDA Feedback Regarding Insulin Glargine Biosimilar

On March 10, Lannett announced that it received feedback from the FDA regarding its insulin glargine biosimilar.  Lannett sought and received comments from the FDA concerning the protocol and statistical analysis plan to be used in the pivotal clinical trial for the product.

Lannett reported that it incorporated this feedback into the design of the pivotal trial, including the type and size of the trial, as well as primary and secondary endpoints, to meet the FDA’s requirements.  Testing related to the production of a commercially scaled batch is underway, and Lannett expects to remain on track to submit an Investigational New Drug Application (IND) to the FDA later this year.  After filing an acceptable IND, Lannett anticipates commencing the pivotal trial in early 2022.

Lannett noted that the proposed pivotal trial is similar to the previously completed first human volunteer pilot study.  As we previously reported, that study assessed the pharmacokinetics, pharmacodynamics, and safety profile of the proposed insulin glargine biosimilar after a single subcutaneous dose compared to the reference product, LANTUS®.  Lannett announced that the study results met all primary endpoints.

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