FDA Approves First Generic Version of Victoza (liraglutide injection)

FDA Approves First Generic Version of Victoza (liraglutide injection)

The U.S. Food and Drug Administration (FDA) has given the green light to the first generic version of Victoza (liraglutide injection) 18 milligram/3 milliliter. This glucagon-like peptide-1 (GLP-1) receptor agonist is prescribed to enhance glycemic control in adults and pediatric patients aged 10 and older with type 2 diabetes, as a supplement to diet and exercise.

First Generic in GLP-1 Class

Last month, the FDA approved the first generic in this category of medications, referencing Byetta (exenatide). With liraglutide injection and some other GLP-1 medications currently in shortage, the FDA has prioritized the review of generic drug applications for these drugs to improve patient access.

“The FDA is committed to supporting the development of complex generic drugs like GLP-1s,” said Iilun Murphy, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “By funding research and providing guidance to the industry, we aim to increase access to necessary medications. Generic drugs offer additional, often more affordable treatment options for patients. Today’s approval highlights the FDA’s ongoing dedication to enhancing patient access to safe, effective, and high-quality generic drug products.”

Type 2 Diabetes Overview

Type 2 diabetes is a chronic condition characterized by the body's inability to use insulin effectively, leading to elevated blood sugar levels. It typically develops over many years and is often diagnosed in adults, though it is increasingly being seen in children, teens, and young adults. Liraglutide works by mimicking the effects of GLP-1 in the pancreas, which is often deficient in type 2 diabetes patients. According to the Centers for Disease Control and Prevention, over 38 million Americans have diabetes, with 90% to 95% of these cases being type 2.

Safety Information

The prescribing information for the newly approved generic liraglutide injection includes a Boxed Warning about the increased risk of thyroid C-cell tumors. Patients with a history of or family history of medullary thyroid carcinoma, or those with multiple endocrine neoplasia syndrome type 2, should not use liraglutide. Additionally, individuals with a prior serious hypersensitivity reaction to liraglutide or any of its components should avoid it. Liraglutide also carries warnings about pancreatitis, sharing liraglutide pens, hypoglycemia when used with certain other drugs, renal impairment or kidney failure, hypersensitivity, and acute gallbladder disease. Common side effects reported in clinical trials include nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation.

FDA’s Efforts to Promote Generic Competition

Addressing the challenges of developing generics and promoting competition is a key aspect of the FDA’s Drug Competition Action Plan. Developing complex drug products like liraglutide can be challenging due to their complex active ingredients, formulations, or delivery methods, often leading to a lack of generic competition. To tackle this issue, the FDA clarifies regulatory expectations for applicants early in the development process, through industry guidance and the pre-ANDA program. These efforts make it easier for manufacturers to develop generic drugs, enhancing patient access to necessary treatments and ensuring that patients in the U.S. can obtain the medicines they need.

Hikma Pharmaceuticals USA Inc. has been granted the approval for generic liraglutide injection. For information on the medicine’s availability, please contact the manufacturer.