The US Food and Drug Administration approved Hikma Pharmaceuticals’ generic version of Novo Nordisk’s diabetes drug, Victoza, on Monday, paving the way for another treatment option in the country. Hikma’s branded generic will now compete with Teva Pharmaceuticals’ authorized generic of Victoza in the United States, which was introduced earlier this year. Authorized generics are exact replicas of branded drugs, sold by a different company with the original drug manufacturer’s consent.
“Generic drugs provide additional treatment options that are generally more affordable for patients,” stated Iilun Murphy, the FDA’s director of the Office of Generic Drugs. Branded generics, like Hikma’s version, are copies of a branded drug that may have slight variances.
Hikma expressed its satisfaction with the FDA’s approval to launch the important medicine and expand access for patients who depend on it. The company anticipates nationwide availability of the drug before the year concludes. The FDA tentatively approved the drug in June.
Victoza, also known as liraglutide, is a first-generation GLP-1, a type of treatment in high demand. It has been on the FDA’s list of scarce drugs since 2023 and is currently limited in supply.
The FDA stated that it prioritizes reviewing generic versions of drugs facing shortages. Victoza is a once-daily injection authorized for use in adults and children aged 10 years or older with type 2 diabetes. Demand for the drug has declined since losing patent protection last year, as patients transition to more effective and less frequent treatments like Novo’s Ozempic and Eli Lilly’s Mounjaro.
The approval of Hikma’s generic version of Victoza provides patients with an additional treatment choice that may be more cost-effective. This move is in line with the FDA’s mission to enhance access to affordable medications for the public.
