In a significant development, the U.S. Food and Drug Administration has granted approval for Hikma Pharmaceuticals to launch a generic version of Novo Nordisk's popular diabetes drug, Victoza. This endorsement paves the way for another alternative for patients in need of this treatment in the United States. Hikma's branded generic will enter the market alongside Teva Pharmaceuticals' authorized generic of Victoza, which was introduced earlier this year.
Authorized generics, like Teva's version, are identical to the original branded drug, with the manufacturer's consent. On the other hand, branded generics, such as Hikma's, may have slight variations from the original formulation. According to Iilun Murphy, the director of the FDA's Office of Generic Drugs, generic drugs offer patients more affordable treatment options, enhancing accessibility to essential medications.
Hikma expressed satisfaction with the FDA's approval, emphasizing its commitment to increasing access and affordability for patients who depend on this medication. Although specific details regarding the drug's launch and pricing were not disclosed, the company's generic version of Victoza received tentative FDA approval earlier this year.
Victoza, also known as liraglutide, is a widely utilized GLP-1 class diabetes treatment. Its demand has surged, with the medication being added to the FDA's shortage list in 2023 due to limited availability. Recognizing the urgency to address medication shortages, the FDA prioritizes the review of generic drugs for drugs in such situations.
Victoza is administered as a once-daily injection for adults and children aged 10 years and older with type 2 diabetes. Despite its popularity, demand for Victoza has declined following the expiration of its patent last year, as patients transition to more advanced once-weekly treatments like Novo's Ozempic and Eli Lilly's Mounjaro. This approval of Hikma Pharmaceuticals' generic version marks a significant milestone in the diabetes treatment market, offering patients additional choices and potentially easing the strain on the supply of this essential medication.