The US Meals and Drug Administration on Monday authorised Hikma Prescribed drugs’ generic model of Novo Nordisk’s diabetes drug, Victoza, clearing the best way for the launch of one other copy of the remedy within the nation.
Hikma’s branded generic will compete with Teva Prescribed drugs approved generic of Victoza in the USA that was launched earlier this 12 months.
Approved generics are the precise copies of branded medicine, offered by one other firm with the branded drug producer’s permission.
Branded generics, akin to Hikma’s, are copies of a branded drug that will include some minor variations.
“Generic drugs provide additional treatment options which are generally more affordable for patients,” stated Iilun Murphy, FDA’s director of the Workplace of Generic Medicine.
Hikma stated 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 corporate stated it expects the drug might be obtainable nationwide earlier than the tip of the 12 months. The drug was tentatively authorised in June by the FDA.
Diabetes drug Victoza, or liraglutide, is a primary technology GLP-1, a category of therapies that has seen overwhelming demand. It has been on the FDA’s scarcity listing since 2023, and at the moment stays in tight provide.
The company stated it prioritizes overview of generic variations of medicine which can be in scarcity.
Victoza is a once-daily injection authorised to be used in adults and youngsters aged 10 years or older with kind 2 diabetes.
Demand for the drug has been falling with the lack of patent safety final 12 months and as sufferers transfer to more practical and once-weekly therapies akin to Novo’s Ozempic and Eli Lilly’s (LLY.N), opens new tab Mounjaro.
