The U.S. Food and Drug Administration on Monday approved Hikma Pharmaceuticals' generic version of Novo Nordisk's diabetes drug Victoza, paving the way for the launch of another treatment in the country.
Hikma's branded generic will compete with Teva Pharmaceuticals' approved generic Victoza, which was launched in the U.S. earlier this year.
Authorized generics are exact copies of branded drugs that are sold by another company with the permission of the branded drug manufacturer.
Branded generic drugs such as Hikma are copies of branded drugs with some minor differences.
“Generic drugs provide additional treatment options that are generally more affordable for patients,” said Iilun Murphy, director of the FDA's Office of Generic Drugs.
“We are pleased to receive FDA approval to launch this important medicine, providing broader access and more affordability to the patients who depend on it,” Hikma said Monday.
The company said it expects the drug to be available nationwide by the end of the year. The drug was tentatively approved by the FDA in June.
The diabetes drug Victoza (liraglutide) is a first-generation GLP-1, a type of treatment that is in overwhelming demand. It has been on the FDA's shortage list since 2023, and there is still a shortage in supply.
The agency said it is prioritizing the review of generic drugs for drugs in short supply.
Victoza is a once-daily injection approved for use in adults and children 10 years and older with type 2 diabetes.
Demand for the drug has declined as it lost patent protection last year and patients move to more effective once-weekly treatments like Novo's Ozempic and Eli Lilly (LLY.N). Open a new tab “Mounjaro”.
