Lannett provides update on insulin glargine biosimilar

Lannett announced it had received comments from the FDA related to the pivotal trial protocol and statistical analysis plan for its biosimilar insulin glargine program. Lannett said that it was comfortable with the feedback, and remains on track to submit an IND to the FDA later this calendar year. The pivotal trial is expected to commence in early 2022, with the BLA to be filed later in 2022 and launch expected in 2023.