Liraglutide Injection Marks Debut as First Authorized Generic GLP-1 Product
In late June, Teva Pharmaceuticals launched the first “generic” GLP-1 (Glucagon-Like-Peptide-1) receptor agonist in the United States, known as Liraglutide injection (6 mg/mL). This authorized generic of Victoza® is a once daily noninsulin injection approved to treat type 2 diabetes in adults and children aged 10 and older. It is also approved to reduce the risk of cardiovascular events like heart attacks and stroke in adults with type 2 diabetes and heart disease.
The FDA defines an authorized generic (AG) drug as the brand name drug that is marketed without the brand name on its label. So other than not having Victoza® on the label, Liraglutide is the exact same drug product as the brand Victoza®. An AG may be marketed by the brand name drug company or another company with the brand’s permission. While it is the same as the brand name product, companies typically choose to sell the AG at a slightly lower cost than the brand.
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- An AG is therapeutically equivalent to its brand name drug because it is the same drug
- An AG is marketed under the brand name drug’s NDA (New Drug Application), therefore it is not listed in the FDA Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book)
- A pharmacy can substituted an AG for the brand name without the prescriber’s approval or a new prescription
- Be alert that GLP-1 medications (originally approved to treat diabetes) are also FDA approved, marketed and prescribed for obesity under a different Trade Name and NDA
- Saxenda® (Liraglutide) is FDA approved for obesity
- AG Liraglutide injection is only approved to treat type 2 diabetes in adults and children aged 10 and older
- Prescriptions for weight loss using the AG Liraglutide would be considered off-label and may be at risk for claim recoupment
- See May 2023 Newsline Best Practices for Dispensing GLP-1 Medications and Reducing Recoupment Risk
I have a Bachelor of Science degree from the University of Wisconsin-River Falls and have been a Certified Pharmacy Technician since 2001. Prior to joining the PAAS team, I was a floating technician, 3rd party district chargeback specialist, and district pharmacy training coordinator. Formerly, I was also an instructor for pharmacy technician certification classes.
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