FDA approves first generic of Victoza, a daily GLP-1 shot for type 2 diabetes

The FDA cleared the first generic copy of Victoza on December 23, 2024, granting Hikma Pharmaceuticals USA Inc. approval for liraglutide injection 18 mg/3 mL ^[1]. It is the first generic of a once-daily GLP-1 injection for lowering blood sugar in type 2 diabetes ^[1].

Victoza is a glucagon-like peptide-1 (GLP-1) receptor agonist. The generic is cleared for use along with diet and exercise to improve blood sugar control in adults and in children as young as 10 who have type 2 diabetes ^[1]. Hikma lists the strength as 6 mg/mL and said it put the product on the market as soon as the approval came through ^[2].

Supply of the drug has been tight. Liraglutide injection is on the FDA's shortage list, along with certain other GLP-1 products, and the agency gives generic applications for shortage drugs priority during review to help patients get them ^[1].

Murphy said generic drugs bring patients "additional treatment options which are generally more affordable" ^[1]. She is director of the Office of Generic Drugs at the FDA's Center for Drug Evaluation and Research ^[1].

A month earlier, the FDA had approved a generic version of Byetta (exenatide), which the agency described as the first generic in this drug class ^[1].

Hikma cited IQVIA data showing US sales of liraglutide injection 6 mg/mL of about $1.3 billion in the 12 months ending October 2024 ^[2]. The company describes itself as one of the three largest suppliers of generic injectable medicines in the US by volume, with more than 170 products ^[2].

"We are very pleased to launch Liraglutide Injection immediately upon receiving US FDA approval," said Dr Bill Larkins, president of injectables at Hikma ^[2].

Diabetes is common in the US. The Centers for Disease Control and Prevention counts more than 38 million Americans with the disease, and 90% to 95% of those cases are type 2 ^[1].

The generic's label carries a boxed warning about thyroid C-cell tumors seen in rats and mice, and says it is unknown whether the drug causes such tumors, including medullary thyroid carcinoma, in people ^[1][2]. People with a personal or family history of medullary thyroid carcinoma, or with the endocrine condition multiple endocrine neoplasia syndrome type 2, should not take it, and neither should anyone who has had a serious allergic reaction to liraglutide or to a component of the product ^[1]. Other warnings cover pancreatitis, kidney injury, gallbladder disease, low blood sugar when the drug is combined with insulin or sulfonylureas, allergic reactions, and the risk of passing a pen between patients ^[1][2]. The label also notes rare reports of pulmonary aspiration during general anesthesia or deep sedation ^[2]. Nausea, diarrhea, vomiting, reduced appetite, indigestion and constipation were the most common side effects in clinical trials ^[1].

Why it matters for patients

The approval adds a second maker of the same molecule at a time when liraglutide has been hard to get ^[1]. The FDA says generics are usually cheaper for patients and fast-tracks applications for medicines in shortage to improve access ^[1]. Whether Hikma's version will sell for less than the brand, and how much supply the company will provide, has not been disclosed ^[2]. The FDA's announcement directs people to the manufacturer for availability information ^[1].

The clearance covers type 2 diabetes only, in adults and children 10 and older ^[1]. Whether generic liraglutide will reach other uses of the molecule has not been reported.

What happens next

Hikma said the medicine went on sale right after approval ^[2]. No price, launch volume or distribution details have been made public ^[1][2]. The FDA has not said when other generic versions of liraglutide might be approved.