FDA Approves First Generic Version of a GLP-1 Injection for Type 2 Diabetes

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On Dec. 23, 2024, FDA approved Hikma Pharmaceuticals USA’s liraglutide injection, the first generic referencing Novo Nordisk’s Victoza (liraglutide injection) 18 mg/3 mL. Liraglutide injection is a glucagon-like peptide-1 (GLP-1) receptor agonist. The approval of Hikma Pharmaceuticals’ generic version is for improving glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes as an adjunct to diet and exercise.

There is currently a drug shortage of liraglutide injection and certain other GLP-1 medications, according to FDA in a press release (1). The agency is thus prioritizing assessment of generic-drug applications for drugs in shortage to help improve patient access to these medications.

“[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,” said Iilun Murphy, MD, director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research, in the press release (1). "Generic drugs provide additional treatment options which are generally more affordable for patients. Today’s approval underscores [FDA’s] continued commitment to advancing patient access to safe, effective, and high-quality generic drug products.”

Liraglutide improves blood sugar levels by having similar effects in the body as GLP-1 in the pancreas. There are often insufficient levels of GLP-1 in type 2 diabetes patients. More than 38 million people in the United States have diabetes, and 90% to 95% of those individuals have type 2 diabetes, according to the Centers for Disease Control and Prevention (1).

FDA, meanwhile, has been addressing challenges related to the development of generics and the promotion of more generic competition. Addressing these challenges is a key part of the agency’s Drug Competition Action Plan and its efforts to help increase patient access to medicines.

The development of complex drug products such as liraglutide can be even more difficult because of their complex active ingredient, formulation, or mode of delivery. For these reasons, many complex drugs lack generic competition. Thus, to address this issue and enable timely development and approval of needed medications, especially complex products, FDA has been working to clarify regulatory expectations for applicants early in the development process, which includes the agency’s guidances for industry and the pre-abbreviated new drug application program. “These efforts make it more feasible for manufacturers to develop generic drugs and can enhance patient access to treatment by helping make these products more available, allowing patients in the United States to obtain the medicines they need,” FDA stated in its press release (1).

FDA had earlier approved the first generic in this class of medications in November 2024, when it approved a generic referencing Byetta (exenatide). The approval for the generic exenatide 1.2 mL and 2.4 mL prefilled pen injection was granted to Amneal Pharmaceuticals (2).

References

1. FDA. FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes. Press Release. Dec. 23, 2024.
2. Amneal Pharmaceuticals. Amneal Resubmits DHE Autoinjector New Drug Application and Receives U.S. FDA Approval of Exenatide, its First Generic Injectable GLP-1 Agonist. Press Release. Nov. 21, 2024.