Lannett expands strategic relationship with HEC for biosimilar Aspart
Lannett has added a new co-development agreement for biosimilar insulin Aspart with its strategic alliance partners within the HEC Group of companies.
Insulin Aspart, a short-acting (fast-acting) insulin typically taken just before eating, is used to treat adults with Type 1 and Type 2 diabetes for the control of high blood sugar.
Total U.S. sales for the 12 months ended December 2020 of various insulin asparts, including Novo Nordisk’s NovoLog, exceeded $6 billion, according to IQVIA, although actual biosimilar market values are expected to be lower.
Insulin Aspart is a distinct product opportunity for Lannett and in addition to the company's previously announced insulin glargine opportunity. Combined, the two insulin products represent a U.S. market of approximately $16 billion, according to IQVIA.
The product is currently in development and Lannett will help manage the remaining clinical and regulatory steps specific for FDA approval to market the product. Lannett will fund most of the clinical development requirements, while HEC continues to develop the product and related manufacturing infrastructure. Lannett and HEC will share in the profits of the venture.
"Biosimilar insulin Aspart is a significant opportunity for us and adds another large, durable and complementary product to our development portfolio," said Tim Crew, Lannett CEO. "The new HEC manufacturing site has the capacity to support double digit market share for both products. Moreover, we believe the clinical program for biosimilar insulin aspart will be quite similar to the clinical program for our biosimilar insulin Glargine product, which is around one year further along in development."
Crew added that only a handful of competitors have the requisite technical expertise and have committed the financial resources, particularly on the manufacturing front, to develop the capacity needed to be successful in biosimilar insulin Aspart or biosimilar insulin Glargine programs.