In a significant move to improve access to diabetes care, the U.S. Food and Drug Administration (FDA) has approved Hikma Pharmaceuticals’ generic version of Victoza (liraglutide), a medication currently facing shortages across the country. This approval, announced on December 23, 2024, paves the way for more affordable treatment options for individuals managing type 2 diabetes.
The FDA has prioritized the review of generic drugs that are in short supply, and Victoza has been on this shortage list since 2023. “Generic drugs provide additional treatment options which are generally more affordable for patients,” stated Iilun Murphy, director of the FDA’s Office of Generic Drugs.
Hikma’s generic formulation received tentative approval earlier this year in June and is expected to be available nationwide before the end of the year. The company has yet to disclose specific pricing details but indicated that it will be offered at a lower cost compared to the branded version of Victoza.
Earlier in 2024, Teva Pharmaceuticals launched its own authorized generic version of Victoza, further increasing competition in the market. Both Hikma’s and Teva’s generics aim to address the growing demand for GLP-1 receptor agonists, a class of medications initially developed for diabetes management but also effective for weight loss.
Victoza is administered as a once-daily injection and is approved for use in adults and children aged 10 years and older with type 2 diabetes. However, as patent protections have expired and patients increasingly turn to newer once-weekly treatments like Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro, demand for Victoza has declined.
The FDA’s approval comes at a crucial time when many patients are seeking effective diabetes management solutions amid ongoing shortages of GLP-1 medications. The agency continues to support the development of complex generics to enhance patient access to essential treatments.
As healthcare providers and patients prepare for this new option, experts emphasize the importance of discussing treatment plans with healthcare professionals to ensure optimal management of diabetes.
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