((Automated translation by Reuters, please see disclaimer https://bit.ly/rtrsauto))
(Added company statement on drug launch to paragraph 7)
The U.S. Food and Drug Administration on Monday approved Hikma Pharmaceuticals HIK.L's generic version of Novo Nordisk's diabetes drug NOVOb.CO Victoza, paving the way for another copy of the treatment to launch in the country.
The branded generic of Hikma will compete with the authorized generic of Victoza from Teva Pharmaceuticals TEVA.TA in the United States, which was launched earlier this year.
Authorized generics are exact copies of brand name drugs, sold by another company with the permission of the brand name drug manufacturer.
Brand-name generics, such as those from Hikma, are copies of a brand-name drug that may have 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.
Hikma said Monday that it was “pleased to have received FDA approval to launch this important medicine and to provide broader, more affordable access to the patients who rely on it.”
The company said it expected the drug to be available nationwide before the end of the year. The drug was provisionally approved in June by the FDA.
The diabetes drug Victoza, or liraglutide, is a first-generation GLP-1, a class of treatments that has seen massive demand. It has been on the FDA's drug shortage list since 2023 and currently remains in limited supply.
The agency said it was prioritizing review of generic versions of drugs in shortage.
Victoza is a once-daily injection approved for adults and children aged 10 years or older with type 2 diabetes.
Demand for the drug has fallen following the loss of patent protection last year and because patients are turning to more effective, one-shot treatments like Novo's Ozempic and Eli Lilly's Mounjaro LLY.N .
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