Following an update, Lannett Company Inc. (NYSE: LCI) increased 11.33% to $0.5927 in pre-market trade on Wednesday and was up 2.23% to $0.5324 in the early trades.
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What kind of update has LCI given?
Today, Lannett (LCI) offered an update on the progress of its biosimilar insulin aspart and insulin glargine products in terms of clinical development. Together with its strategic partnership partner, the HEC Group of enterprises, Lannett is exploring both items. The business claimed that when animals were dosed with identical amounts of the medications through the subcutaneous method, the findings from the trial comparing Lannett/HEC biosimilar insulin aspart to US NovoLog (the reference biologic) showed the products were extremely comparable.
Data from the trial will be provided to the FDA as part of LCI’s request for a Biosimilar Biological Product Development (BPD) Type II meeting, which is anticipated in the first half of the calendar year 2023. Positive trial findings represent a significant milestone in the clinical development of LCI’s biosimilar insulin aspart. LCI expects to submit an IND application this summer, start the pivotal trial by the fall of 2023, and wrap it up in the summer of 2024. If all goes well, LCI will submit the Biologics License Application (BLA) at the end of 2024 and may market the product in 2025.
The examination of the pivotal trial findings for Lannett’s biosimilar insulin glargine is still ongoing, the company added, although top-line data should now be ready by the end of February 2023. Well over 95% of the primary sample data from the pivotal study have been tested by a reputable UK-based lab; however, testing was halted for equipment upkeep and calibration. The testing was therefore not finished by the lab’s year-end closing, which added to the delay. After each sample has been examined, the data will be statistically analyzed.
What further plans does LCI have?
Even while Lannett (LCI) expects the BLA application for its biosimilar insulin glargine to be delayed by around two months to mid-year 2023, its objective for a possible release later during the first half of 2024 remains within reach. Additionally, LCI is still confident that the trial will satisfy its clinical goals and it wants to take advantage of an FDA pre-submission discussion to improve the chances of receiving a first-pass approval and perhaps shorten the review period.