Hikma launches first FDA-approved generic of Victoza in the US
Hikma's generic liraglutide injection gives U.S. patients a second source of a daily GLP-1 for type 2 diabetes that the FDA lists as in shortage, though pricing was not disclosed.
Hikma Pharmaceuticals has received FDA approval for and launched a generic version of Victoza, the daily GLP-1 injection liraglutide, in the United States [1]. The FDA approved the first generic referencing Victoza on Dec. 23, 2024, and granted the approval to Hikma Pharmaceuticals USA Inc. [2]. Hikma said it launched the 6 mg/mL liraglutide injection immediately upon approval and announced the launch on Dec. 26, 2024 [1].
Generic liraglutide injection is a glucagon-like peptide-1 (GLP-1) receptor agonist. It is indicated, as an adjunct to diet and exercise, to improve blood sugar control in adults and in children 10 years of age and older with type 2 diabetes [1][2]. The FDA describes it as a once-daily injection [2]. Hikma said the approval does not give it or anyone else the right to market the product outside the United States [1].
The FDA noted that it approved the first generic in the GLP-1 class last month, a generic referencing Byetta (exenatide) [2].
Hikma did not disclose a price for the generic in its announcement [1]. According to IQVIA, U.S. sales of liraglutide injection 6 mg/mL were approximately $1.3 billion in the 12 months ending October 2024 [1]. Hikma said it is a top-three supplier of generic injectable medicines by volume in the U.S., with a portfolio of more than 170 products [1].
"We are very pleased to launch Liraglutide Injection immediately upon receiving US FDA approval, providing US healthcare professionals and patients with this important generic treatment of diabetes," said Dr Bill Larkins, president of injectables at Hikma [1].
The FDA said liraglutide injection and certain other GLP-1 medications are currently in shortage, and that the agency prioritizes review of generic applications for drugs in shortage to help improve patient access [2]. "Generic drugs provide additional treatment options which are generally more affordable for patients," said Iilun Murphy, M.D., director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research [2]. The FDA said patients should contact the manufacturer for information about availability [2].
The approved labeling for the generic carries a boxed warning about thyroid C-cell tumors seen in rodents, and the product is contraindicated in people with a personal or family history of medullary thyroid carcinoma or with multiple endocrine neoplasia syndrome type 2 [1][2]. Other warnings cover pancreatitis, the risk of sharing a pen between patients, low blood sugar when used with insulin or sulfonylureas, kidney problems, serious allergic reactions including anaphylaxis and angioedema, gallbladder disease, and pulmonary aspiration during general anesthesia or deep sedation [1][2]. The most common side effects reported in clinical trials were nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation [2].
Why it matters for patients
Liraglutide is a different medicine from semaglutide (sold as Ozempic, Wegovy and Rybelsus) and tirzepatide (Mounjaro and Zepbound), so this launch does not add a generic competitor to those products.
The FDA approved this generic because liraglutide injection was in shortage, and the agency says generics are generally more affordable and add treatment options [2]. But Hikma did not state a price for its product [1], and it has not been reported how widely the generic will be stocked in pharmacies or how insurers will cover it.
Both Hikma's and the FDA's announcements describe the approved use as improving blood sugar control in type 2 diabetes [1][2]. Weight management is not part of the indication either announcement describes. The safety information is the same as for the brand: the boxed warning about thyroid C-cell tumors, the contraindications, and the warnings about pancreatitis, kidney problems, gallbladder disease and hypoglycemia apply to the generic as well [1][2]. Anyone taking or considering liraglutide can read the same labeling regardless of which version the pharmacy dispenses.
One difference patients may notice is packaging and the name on the pen, since this is a separate product from the brand [1]. How quickly supply reaches pharmacies has not been disclosed beyond Hikma's statement that it launched the product immediately upon approval [1].
Sources
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