Tony Hagen is senior managing editor for The Center for Biosimilars®.
Lannett and HEC Pharm are developing an insulin aspart biosimilar on the heels of their insulin glargine codevelopment project.
Lannett of Trevose, Pennsylvania, is aiming for a share of the estimated $6 billion market for insulin aspart in a partnership to develop a biosimilar with HEC Pharm of China. HEC will handle the manufacturing preparations and some of the clinical development work and Lannett will fund and manage clinical and regulatory steps for FDA approval.
Insulin aspart is a fast-acting insulin used for the treatment of type 1 and type 2 diabetes in adults. There are various products on the market, but one of the leaders is NovoLog, a NovoNordisk brand.
Lannet, traditionally a generics developer and distributor, and HEC Pharm, which has an extensive sales network in China, also are developing a biosimilar to insulin glargine, a long-acting insulin. Long-acting insulin peaks in the bloodstream later and remains active for significantly longer than short-acting insulin.
In June 2020, Lannett approached the FDA to present clinical, chemistry, manufacturing, and control data for the insulin glargine biosimilar candidate and reported that the meeting was positive and productive. The company hopes to file a 351(k) biosimilar application with the FDA in 2022. HEC Pharm is also a partner in this effort.
Insulin products were only recently added to the list of proteins that can be approved as biosimilars under the Biologics Price Innovation and Competition Act (BPCIA). The March 2020 change was done in part to spur the development of a competitive insulin market that would bring down prices and improve access for patients. So far, no insulin products have been approved under the BPCIA.
Mylan and Biocon Biologics in June 2020 received FDA approval for an insulin glargine (Semglee) referencing Lantus (Sanofi), but under a different regulatory pathway, so the product is not technically a biosimilar. However, the companies said at the time of approval that they intend to file for an official biosimilar designation.
Lannett CEO Tim Crew said the company’s development of an insulin glargine biosimilar is about a year ahead of the insulin aspart effort. “Biosimilar insulin aspart is a significant opportunity for us and adds another large, durable, and complementary product to our development portfolio.”