The FDA first approved Victoza in 2010 for Type 2 diabetes, later expanding its use in 2019 as a pediatric, injectable treatment for patients 10 or older. Hikma’s generic includes similar warnings to the brand-name drug, such as risks of thyroid C-cell tumors, pancreatitis, hypoglycemia, kidney failure and acute gallbladder disease.
The injectable GLP-1 is indicated to improve glycemic control in patients 10 and older. This marks the second GLP-1 medicine with a generic option. In November, the FDA approved a generic for Byetta (exenatide), another diabetes therapy.
A few other drugmakers are preparing to enter the GLP-1 market, which remains dominated by Eli Lilly and Novo Nordisk. In June, Teva Pharmaceuticals launched its generic version of Victoza. Sandoz plans to release a generic for Ozempic (semaglutide) when the market opens in 2030.
