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The US Food and Drug Administration on Monday approved Hikma Pharmaceuticals’ generic version of Novo Nordisk’s diabetes drug, Victoza, clearing the way for the launch of another copy of the treatment in the country.
Hikma’s branded generic will compete with Teva Pharmaceuticals authorized generic of Victoza in the United States that was launched earlier this year.
Authorized generics are the exact copies of branded drugs, sold by another company with the branded drug manufacturer’s permission.
Branded generics, such as Hikma’s, are copies of a branded drug that may contain some minor differences.
“Generic drugs provide additional treatment options which are generally more affordable for patients,” said Iilun Murphy, FDA’s director of the Office of Generic Drugs.
Hikma said on Monday it was “pleased to have FDA approval to launch this important medicine and to provide broader access and greater affordability for the patients who rely on it”.
The company said it expects the drug will be available nationwide before the end of the year. The drug was tentatively approved in June by the FDA.
Diabetes drug Victoza, or liraglutide, is a first generation GLP-1, a class of treatments that has seen overwhelming demand. It has been on the FDA’s shortage list since 2023, and currently remains in tight supply.
The agency said it prioritizes review of generic versions of drugs that are in shortage.
Victoza is a once-daily injection approved for use in adults and children aged 10 years or older with type 2 diabetes.
Demand for the drug has been falling with the loss of patent protection last year and as patients move to more effective and once-weekly treatments such as Novo’s Ozempic and Eli Lilly’s (LLY.N), opens new tab Mounjaro.
English (US)