The US Food and Drug Administration has recently given the green light to a generic version of the daily injectable GLP-1 medicine liraglutide for individuals with type 2 diabetes. This approval paves the way for more affordable options to enter the market, addressing a shortage in availability.
Liraglutide, known by the brand name Victoza for diabetes treatment, is an earlier version of the same class as semaglutide, the active ingredient in Ozempic, both manufactured by Novo Nordisk, a Danish pharmaceutical company.
The generic liraglutide, produced by Hikma Pharmaceuticals USA, is expected to be available nationwide by the end of the year. While the exact pricing has not been disclosed, it is anticipated to be lower than the branded Victoza, which can cost between $500 and $815 per package.
Dr. Harlan Krumholz, a cardiologist at Yale University, highlighted the benefits of having another generic version of liraglutide available for patients. However, he also noted that newer GLP-1 drugs, administered as weekly injections, have shown stronger benefits, especially for patients with obesity.
Although the introduction of the generic liraglutide is a positive step towards affordability, it may take multiple manufacturers entering the market to significantly reduce the price. Dr. Aaron Kesselheim, a professor at Harvard Medical School, explained that typically, it requires four or more independent generics to achieve substantial price reductions.
It's important to differentiate between generic drugs, authorized generics, and compounded drugs. Generic drugs are copies of brand-name drugs developed by other companies, while authorized generics are identical to branded drugs but without the brand name on the label. Compounded drugs, made by pharmacies, are not as closely regulated as generics and branded medicines.
The FDA's prioritization of generic drug applications for medications in shortage aims to enhance patient access to essential treatments. Dr. Jody Dushay, an assistant professor at Harvard Medical School, expressed hope that the generic liraglutide will be significantly more affordable than the branded versions and reach patients promptly.
In conclusion, the approval of the generic liraglutide offers a promising solution to the shortage of diabetes medications, potentially improving accessibility and affordability for individuals with type 2 diabetes.
