LANNETT COMPANY, INC. On January 4, 2023, Lannett Company, Inc. provided an update on the clinical advancement and development of its biosimilar insulin aspart and biosimilar insulin glargine products. Lannett is developing both products with its strategic alliance partner, the HEC Group of companies (HEC). The company said results from the study of Lannett/HEC biosimilar insulin aspart versus US NovoLog® (the reference biologic) indicated the products were highly comparable when animals were dosed with equal quantities of the drugs via subcutaneous route.
Data from the study will be submitted to the FDA as part of the company's request, expected in the first half of calendar 2023, for a Biosimilar Biological Product Development (BPD) Type II meeting. The company also said that analysis of the pivotal trial results for its biosimilar insulin glargine continues, though it now anticipates top-line data to be available by the end of February 2023.
