Generic Liraglutide (Victoza) Becomes First Generic GLP-1 Receptor Agonist

Credit: Victoza

Teva Pharmaceuticals has announced the launch of an authorized generic of liraglutide (Victoza) in the United States for patients with type 2 diabetes, making it the first-ever generic glucagon-like peptide-1 (GLP-1) receptor agonist.¹

“By launching an authorized generic for Victoza® (liraglutide injection 1.8mg), we are providing patients with type 2 diabetes another option for this important treatment,” Ernie Richardsen, SVP, Head of US Commercial Generics at Teva, said in a press release.¹ “In addition to strengthening Teva's diverse complex generics portfolio, we are providing the first generic GLP-1 product to the U.S. marketplace, demonstrating once again our ability to sustain a generics powerhouse.”

According to the American Diabetes Association, in 2021, 38.4 million people in the US, or 11.6% of the population, had diabetes, with an estimated 1.2 million new diabetes diagnoses every year. The total cost of diabetes in the US in 2022 was estimated to be $412.9 billion, including $306.6 billion attributed to direct medical costs and $106.3 billion attributed to indirect costs, underscoring the need for low-cost, effective medications to address the growing incidence and financial burden.²

Liraglutide was first approved by the US Food and Drug Administration (FDA) in 2010 as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. In 2017, a new indication was approved to reduce the risk of major adverse cardiovascular events, heart attack, stroke, and cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.^3,4

The decision was based on results from the landmark LEADER trial demonstrating that liraglutide’s significant reduction in the risk of a three-component endpoint consisting of cardiovascular death, non-fatal heart attack, or non-fatal stroke by 13% versus placebo (P = .01) with an absolute risk reduction (ARR) of 1.9%. Additionally, treatment with liraglutide resulted in a 22% reduction in cardiovascular death (ARR, 1.3%) and a 15% reduction in all-cause death (ARR, 1.4%).⁴

In 2019, liraglutide received FDA approval for the treatment of type 2 diabetes in pediatric patients 10 years of age or older, making it the first non-insulin drug approved to treat type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000. Its efficacy and safety for reducing blood sugar in patients with type 2 diabetes was studied in several placebo-controlled trials in adults and a single placebo-controlled trial with 134 pediatric patients 10 years of age and older for > 26 weeks. Results showed approximately 64% of patients in the pediatric study had a reduction in their hemoglobin A1c below 7% while on liraglutide, compared to 37% who achieved these results with placebo.⁴

In 2017, Teva filed an abbreviated New Drug Application with the FDA, seeking approval to market the generic version of Novo Nordisk’s liraglutide injection. In 2019, Teva and Novo Nordisk reached a settlement on the US patent litigation case for liraglutide, allowing Teva to launch a generic version of liraglutide beginning March 22, 2023, unless the liraglutide patents were no longer in force or another generic version of liraglutide was marketed.^5,6

According to a release from Teva, liraglutide had annual sales of $1.656 billion as of April 2024.¹

References:

1. ^{Teva Announces Launch of Authorized Generic of Victoza® (liraglutide injection 1.8mg), in the United States. June 24, 2024. Accessed June 24, 2024. https://www.businesswire.com/news/home/20240623654311/en/Teva-Announces-Launch-of-Authorized-Generic-of-Victoza%C2%AE-liraglutide-injection-1.8mg-in-the-United-States}
2. ^{American Diabetes Association. Statistics About Diabetes. Accessed June 24, 2024. https://diabetes.org/about-diabetes/statistics/about-diabetes}
3. ^{FDA Approves Novo Nordisk's Victoza for Adults With Type 2 Diabetes. HCPLive. January 26, 2010. Accessed June 24, 2024. https://www.hcplive.com/view/novo_nordisk_victoza_diabetes}
4. ^{Drugs.com. Victoza FDA Approval History. June 17, 2019. Accessed June 24, 2024. https://www.drugs.com/history/victoza.html}
5. ^{Teva Pharmaceuticals. Teva Confirms Generic Victoza® Patent Challenge in the United States. February 2, 2017. Accessed June 24, 2024. https://www.tevausa.com/news-and-media/press-releases/teva-confirms-generic-victoza-patent-challenge-in-the-united-states/}
6. ^{Novo Nordisk. Novo Nordisk settles US patent litigation case on Victoza® (liraglutide) with Teva. March 18, 2019. Accessed June 24, 2024. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=414#}