In a move aimed at expanding affordable treatment options for those living with diabetes, the U.S. Food and Drug Administration (FDA) has approved Hikma Pharmaceuticals’ generic version of Novo Nordisk’s diabetes medication, Victoza. The approval marks an important milestone in the fight against diabetes, especially as the original brand-name drug has faced ongoing shortages in the country. The generic version of Victoza, which contains liraglutide, is expected to offer patients a more cost-effective alternative to its brand-name counterpart.
Victoza, a once-daily injectable medication, has been widely prescribed for patients with type 2 diabetes. It works by mimicking a hormone called GLP-1, which helps regulate blood sugar levels, slow down digestion, and reduce appetite. While the drug has been effective for many, it has faced a decline in demand due to the emergence of newer and more convenient treatments in the same GLP-1 class, such as Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro. These newer drugs offer the advantage of being administered less frequently, with some requiring only a once-weekly injection.
The FDA’s approval of the generic version of Victoza is part of a broader effort to address the ongoing shortages of important medications in the U.S. The agency has prioritized the review of generic drugs that are in short supply, recognizing that they offer additional treatment options that are typically more affordable for patients. In the case of Victoza, the shortage has persisted since 2023, which has further fueled the need for more affordable alternatives.
Iilun Murphy, the FDA’s Director of the Office of Generic Drugs, commented on the significance of the approval, saying, “Generic drugs provide additional treatment options, which are generally more affordable for patients.” This focus on affordability is crucial, especially as the high cost of prescription medications continues to be a barrier for many individuals seeking effective treatment.
Hikma Pharmaceuticals’ generic version of Victoza received tentative approval in June, and now that it has been officially approved, it is expected to become available in the U.S. market. However, the company has not yet disclosed the pricing for the generic version. This move comes shortly after Teva Pharmaceuticals launched its own authorized generic version of Victoza earlier this year, signaling increased competition in the market.
Liraglutide, the active ingredient in Victoza, belongs to a class of drugs known as GLP-1 agonists. These drugs were initially developed to treat diabetes but have also gained approval for weight management. The rising popularity of GLP-1 medications for both diabetes and obesity treatment has shifted the landscape of diabetes care in recent years. However, with the loss of patent protection for Victoza last year, the market is now seeing more choices for patients, offering both convenience and cost savings.
While demand for Victoza has decreased in favor of longer-acting drugs like Ozempic and Mounjaro, the approval of a generic version provides a much-needed solution for individuals who continue to rely on liraglutide for managing their type 2 diabetes. With the growing cost pressures on the healthcare system, having access to affordable alternatives can make a significant difference in improving patient outcomes and quality of life.
As the landscape of diabetes treatments continues to evolve, the approval of generic drugs like Hikma’s version of Victoza is an important step in ensuring that more patients can access effective and affordable medications. The hope is that this move will not only alleviate the ongoing shortage but also encourage further competition and innovation within the pharmaceutical industry.