The FDA has approved the first generic version of a GLP-1 receptor agonist specifically designed for weight loss. Teva Pharmaceuticals announced that the generic form of liraglutide (Saxenda) is now cleared for use, marking a significant step in expanding access to obesity treatments.
Who Can Use It?
The new generic is indicated for:
- Adults with obesity, or those who are overweight with at least one related health condition, in combination with diet and exercise
- Adolescents ages 12 to 17 with obesity and weighing more than 132 pounds
Originally approved in 2014 for chronic weight management in adults, liraglutide’s use was expanded in 2020 to include teens.
Why This Matters
Demand for GLP-1 weight-loss medications has surged, but cost and supply shortages have made access difficult. Teva stated that this approval should help meet the “increased demand” for therapies in this category.
While this is the first GLP-1 generic for weight loss, generics of related medications — such as liraglutide for diabetes (Victoza) and exenatide (Byetta) — already exist.
Effectiveness Compared to Newer Drugs
In 56-week clinical trials, liraglutide led to an average weight loss of about:
- 12.3 pounds more than placebo in adults
- 9.9 pounds more than placebo in adolescents
These results, while meaningful, are modest compared with newer GLP-1 drugs like tirzepatide (Zepbound) and semaglutide (Wegovy), which showed much greater average weight reductions in head-to-head trials.
Important Safety Information
The label for generic liraglutide carries a boxed warning for the risk of thyroid C-cell tumors. It should not be used by individuals with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
Other serious risks include pancreatitis, gallbladder disease, kidney injury, heart rate increases, severe gastrointestinal reactions, and suicidal thoughts.
The most common side effects include:
- Nausea, vomiting, diarrhea, and constipation
- Injection site reactions
- Headache, dizziness, or fatigue
- Abdominal pain and indigestion
The drug is not approved for children under age 6 and should only be used during pregnancy if the potential benefits outweigh the risks.