FDA Approves First Generic of Liraglutide Injection to Improve Glycemic Control in Patients with Type 2 Diabetes

The US FDA today approved the first generic referencing the glucagon-like peptide-1 receptor agonist (GLP-1 RA) liraglutide (Victoza; Hikma Pharmaceuticals), an 18 mg/3 mL injection, to improve glycemic control in patients aged 10 years and older with type 2 diabetes (T2D) as an adjunct to diet and exercise.

Liraglutide, initially approved for adults with type 2 diabetes in 2010, was approved in 2014 for chronic weight management in adults with a body mass index ≥30 kg/m2 with at least 1 weight-related comorbidity, as an adjunct to a reduced calorie meal plan and increased exercise. Then, in 2020, it became the first FDA-approved therapy for adolescents with obesity in more than 10 years.

Due to ongoing shortages of liraglutide injection and other GLP-1 RAs, generic drug applications for medications in this area are a priority, according to a press release from the FDA announcing the approval. The first generic in this class of medications to receive FDA approval, a generic referencing exenatide (Byetta), was approved in November 2024.

“The FDA supports development of complex generic drugs, such as GLP-1s, by funding research and informing industry through guidance as part of our ongoing efforts to increase access to needed medications,” Iilun Murphy, MD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, said in the December 23, 2024, press release. "Generic drugs provide additional treatment options which are generally more affordable for patients. Today’s approval underscores the FDA’s continued commitment to advancing patient access to safe, effective and high-quality generic drug products.”

The most commonly reported adverse events in clinical trials for liraglutide injection were nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation, according to the FDA. The approved generic liraglutide also includes a boxed warning for an increased risk of thyroid C-cell tumors, meaning those who have had medullary thyroid carcinoma or whose family members have should not use liraglutide. Patients with multiple endocrine neoplasia syndrome type 2 should also not use liraglutide, according to the statement.

Reference: FDA approves first generic of once-daily GLP-1 injection to lower blood sugar in patients with type 2 diabetes. News release. US Food and Drug Administration. December 23, 2024. Accessed December 23, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-once-daily-glp-1-injection-lower-blood-sugar-patients-type-2-diabetes