On May 2, The Lannett Company Inc. disclosed that it had filed for Chapter 11 bankruptcy. The company has been working on an insulin glargine biosimilar candidate. On April 4th Lannett reported that its biosimilar insulin had met all primary and secondary endpoints and was not associated with serious adverse events. This was a pivotal clinical trial performed in a double-blind randomized crossover study manner.
The company said that the bankruptcy filing should have no impact on business operations as it pursues its restructuring plan. A filing of a biologic licensing application for its insulin glargine biosimilar would be possible as early as Q3 of this year. In a May 1 press release from the Trevose, Pennsylvania–based company, it stated that “The company is working to complete this financial restructuring transaction by June 18, 2023, and the Company continues to anticipate near-term product launches and significant progress on more specialized technologies and capabilities supporting new product development.”
How will this move affect the company’s commercialization pathway for its biosimilar insulins? A spokesman for Lannett told Biosimilars Review & Report, “The restructuring transactions we announced will significantly strengthen Lannett’s financial position and position us to implement our business plan. We are driving ahead in our efforts to launch the potentially highly-profitable biosimilar insulin glargine and insulin aspart, and anticipate filing the BLA for the biosimilar insulin glargine in calendar year 2023, with a potential launch in calendar year 2024.”
Generic Drug Companies Hitting Hard Times
Lannett cited “continued competitive pressures” on its current portfolio as the major factor in its filing. This comes days after another generic manufacturer, Akorn, announced that it was dissolving the company. Both announcements are discouraging signs for two reasons: First and foremost, generic companies like these are the bulwark against continuing drug shortages in the US, particularly for generics that are decades-old, low-profit medications that are routinely used throughout the health system.
Second, traditionally generic manufacturers like Lannett and Amneal Pharmaceuticals are prime candidates to continue the momentum recently gained by the biosimilar industry, and to produce biosimilars from lower-revenue biologics in the future. For example, insulins are facing heavy competition and great pricing pressures, with unceasing demand. A generic manufacturer producing a new biosimilar insulin may have a good chance of achieving long-term sustainability with its larger portfolio of generic products.