Liraglutide: The First GLP-1 Generic Referencing Victoza

By: Mazal Borukhova, PharmD Candidate c/o 2026, Jacqueline Demirjian, PharmD Candidate c/o 2029, Alicia Lumia, PharmD Candidate c/o 2029, Hailey Sandoval, PharmD Candidate c/o 2029

Type 2 diabetes mellitus (T2DM) is a chronic disease that occurs when the body is unable to regulate blood glucose levels. There are many risk factors that can contribute to the development of T2DM, including family history, poor diet, lack of exercise, obesity, and individuals 45 years or older. Some lifestyle modifications patients can make are maintaining a balanced diet, weight reduction, and engaging in moderate to high intensity exercise for at least 150 minutes a week, spaced across at least three days.^{1, 10} There are several pharmacological treatments available for the management of T2DM, and recently, Glucagon-Like-Peptide-1 Receptor Agonists (GLP-1 RA) have become increasingly popular as a form of first-line therapy.

Glucagon-like peptide-1 (GLP-1) is an incretin hormone that helps lower serum glucose levels by stimulating the release of insulin from the pancreas. For patients whose bodies have a difficult time producing insulin or whose cells are desensitized to insulin, a GLP-1 agonist can promote the secretion of insulin, thereby bringing their hyperglycemia under control.² Victoza, the brand name for liraglutide, is an example of a long-acting GLP-1 RA, which is commonly used as an agent for T2DM. When used alongside appropriate diet and exercise, liraglutide improves glycemic control in patients 10 years or older. Liraglutide is administered via subcutaneous injection in either the upper arm, thigh, or abdomen, and can be taken with or without food. Common side effects of liraglutide may include irritation at the injection site, decreased appetite, constipation, and headache.⁹

Generic medications are extremely important within modern healthcare. They can help in providing alternatives to brand-name drugs while also having the same therapeutic benefits. The availability of generics increases patient access to needed treatments, lowers overall healthcare costs, and promotes medication adherence.³ “According to the FDA, the cost of a generic drug can be 80%–85% lower than the innovator’s branded product”¹² This price difference is usually because of less research, development, and marketing costs since generics do not need extensive trials when the patent for the brand name drug expires. The FDA requires generic medications to have the same standards for safety, efficacy, and quality as their brand-name counterpart. These generic drugs have to show bioequivalence, meaning they bring the same active ingredient into the bloodstream at nearly the same rate as the name-brand drug. This ensures that generics have the same medicinal effects without any change in treatment outcomes.¹²

Generic drugs being available to patients promotes competition within the pharmaceutical industry, which can impact the pricing of all drugs. When multiple manufacturers make the same generic medication, it makes costs even lower, which is beneficial to patients and healthcare systems.⁶ The high cost of medication can often lead to non-adherence, where patients skip or discontinue treatment because of financial burdens. Generics provide an affordable alternative, which can help reduce financial burdens and improve the likelihood of patients adhering to their prescribed treatment regimens. This is especially important in patients with chronic conditions where continuous medication use is necessary for disease management.³ Additionally, generic medications are necessary for a sustainable healthcare system. They have the same effectiveness as their brand-name counterparts at a much lower cost, improving patient access and adherence while also reducing the overall healthcare costs for the public. When more patents expire and generics enter the market, their role in making healthcare more affordable and accessible continues to grow.⁸

Victoza by Novo Nordisk was initially approved by the FDA in January 2010 for the treatment of diabetes. Its indication was further expanded in June 2019 for the use of pediatric patients who are at least 10 years old.¹¹ The authorized generic of Victoza was released by Teva Pharmaceuticals in June 2024, while the traditional generic by Hikma Pharmaceuticals was released in December 2024.^13,7 This raises a question: if Hikma Pharmaceuticals is recognized by the FDA as the manufacturer of the first generic of liraglutide, then how could Teva’s authorized generic be released earlier? The answer lies in the differences between an authorized generic and a traditional generic. According to the FDA, an authorized generic is “an approved brand name drug that is marketed without the brand name on its label.”⁵ Essentially, all the components of the authorized generic mimic that of the brand, except for the labeling on the packaging. The brand-name manufacturer can choose to either release the authorized generic themselves or give permission to other manufacturers to do so. A traditional generic, on the other hand, is the “same as the brand-name drug in active ingredient, conditions of use, dosage form, strength, route of administration, and (with certain permissible differences) labeling.”⁵ Traditional generics tend to have differences with their inactive ingredients, provided that those ingredients do not interfere with the drug’s safety or effectiveness. Additionally, manufacturers must submit an Abbreviated New Drug Application (ANDA) to the FDA. By submitting an ANDA, the manufacturer states that the traditional generic and the brand name are bioequivalent and that the generic has the same standards of quality and manufacturing as the brand-name drug.⁵ With this understanding, it becomes clear that while Teva did produce an authorized generic of liraglutide, it was done under Novo Nordisk’s original NDA and not through the traditional ANDA approval process. Although Teva submitted an ANDA to the FDA, it has not yet been approved.¹⁴ This, coupled with the fact that Teva’s formulation is identical to the brand-name drug, explains why Teva’s generic is classified as an authorized generic. Therefore, Hikma Pharmaceuticals is the first to produce a traditional generic referencing Victoza through an approved ANDA.

Generics of essential medications play a crucial role in providing the public with more accessible and affordable medications that are not compromised in their efficacy, safety, and quality. By providing more affordable options for treatment in patients who are in need, generic medications are able to empower patients to increase their adherence to their treatment regimen. Dr. Iilun Murphy, M.D., the director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, emphasized the importance of generic medications by stating, “Generic drugs provide additional treatment options which are generally more affordable for patients. [Liraglutide’s] approval underscores the FDA’s continued commitment to advancing patient access to safe, effective, and high-quality generic drug products.”⁴ As more medications for T2DM are being developed, the availability of these generics will increase over time. This is crucial for diabetic patients, who will likely require long-term treatment, as it will lessen their financial burden and allow them to continue with the appropriate therapy needed to manage their condition.

References

1. CDC. Diabetes. CDC. https://www.cdc.gov/diabetes/risk-factors/index.html.  Published 05/15/2024.
2. Collins L, Costello RA. Glucagon-Like Peptide-1 Receptor Agonists. In: StatPearls. Treasure Island (FL): StatPearls Publishing; February 29, 2024. https://pubmed.ncbi.nlm.nih.gov/31855395/
3. DrugPatentWatch. The Impact of Generic Drugs on Healthcare Costs – DrugPatentWatch – Make Better Decisions. Published August 21, 2024. https://www.drugpatentwatch.com/blog/the-impact-of-generic-drugs-on-healthcare-costs/
4. FDA. FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes. U.S. Food & Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-once-daily-glp-1-injection-lower-blood-sugar-patients-type-2-diabetes. Last Updated 12/23/2024.
5. FDA. FDA List of Authorized Generic Drugs. U.S. Food & Drug Administration. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/fda-list-authorized-generic-drugs. Last Updated 01/13/2025.
6. FDA. Generic Competition and Drug Prices. U.S. Food & Drug Administration. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/generic-competition-and-drug-prices.  Last Updated 10/17/2024.
7. Hikma. Hikma receives FDA approval and launches the generic version of Victoza®, Liraglutide, in the US. Hikma. https://www.hikma.com/news/hikma-receives-fda-approval-and-launches-the-generic-version-of-victoza-liraglutide-in-the-us/. Last Updated 12/26/2024.
8. Kritz F. AAM 2024 Report Shows Billions in Biosimilar and Generic Savings. Specialty Pharmacy Continuum. https://www.specialtypharmacycontinuum.com/Online-First/Article/11-24/Biosimilars-Generics-445-Billion-Savings/75360. Published 11/05/2024.
9. Liraglutide. In: Lexi-Drugs. UpToDate Inc. Updated February 26, 2025. Accessed March 5, 2025. https://online-lexi-com.jerome.stjohns.edu/lco/action/doc/retrieve/docid/patch_f/2144379?cesid=2RnaNEL5k06&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dliraglutide%26t%3Dname%26acs%3Dfalse%26acq%3Dliraglutide
10. Raveendran AV, Chacko EC, Pappachan JM. Non-pharmacological Treatment Options in the Management of Diabetes Mellitus. Eur Endocrinol. 2018;14(2):31-39. doi:10.17925/EE.2018.14.2.31 https://pubmed.ncbi.nlm.nih.gov/30349592/
11. Stewart J. Victoza FDA Approval History. Drugs.com. https://www.drugs.com/history/victoza.html. Last Updated 11/12/2024.
12. Straka RJ, Keohane DJ, Liu LZ. Potential Clinical and Economic Impact of Switching Branded Medications to Generics. Am J Ther. 2017;24(3):e278-e289. doi:10.1097/MJT.0000000000000282 https://pubmed.ncbi.nlm.nih.gov/26099048/
13. Teva. Teva Announces Launch of Authorized Generic of Victoza® (liraglutide injection 1.8mg), in the United States. Teva. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2024/Teva-Announces-Launch-of-Authorized-Generic-of-Victoza-liraglutide-injection-1.8mg-in-the-United-States/default.aspx. Published 06/24/2024.
14. Teva. Teva Confirms Generic Victoza® Patent Challenge in the United States. Teva. https://www.tevapharm.com/news-and-media/latest-news/teva-confirms-generic-victoza-patent-challenge-in-the-united-states/. Published 02/02/2017.