The first generic version of the first-generation obesity treatment medication has been approved in the United States. The U.S. Food and Drug Administration (FDA) granted approval on the 23rd (local time) for the generic product of Victoza (ingredient: liraglutide), a treatment for type 2 diabetes in patients aged 10 and older. It is expected that the FDA will soon approve the generic for obesity treatment as well, as a drug with the same active ingredient known as Saxenda was released later.
The generic version of Victoza, developed by UK Hikma Pharmaceuticals, is set to be launched across the United States by the end of this year. A generic medication is made to have the same ingredients, formulation, and dosage as the original drug. Once the patent for the original drug expires, multiple pharmaceutical companies can create generic medications using publicly available technology.
This approval came approximately seven months after the expiration of Victoza's substance patent. The FDA's approval of generic medications in the glucagon-like peptide-1 (GLP-1) category marks the second instance, following the approval of a generic medication from Amgen that replicated AstraZeneca's diabetes treatment Byeleta (exenatide) in the United States.
The GLP-1 hormone in the human body promotes the secretion of insulin, which regulates blood sugar levels. At the same time, it slows down the digestion of food in the stomach, leading to a sensation of fullness and appetite suppression, which aids in weight loss. Liraglutide, which mimics GLP-1, was released as Victoza in 2010 for diabetes treatment, and later as Saxenda in 2014 for obesity treatment. Denmark's Novo Nordisk also launched Ozempic and Wegovy, both GLP-1 analogs, as diabetes and obesity drugs, respectively, in 2017 and 2021.
First-generation GLP-1 drugs are considered less advanced than newer medications. While Ozempic and Wegovy are administered via a weekly injection, the earlier Victoza and Saxenda require a daily injection. The efficacy of liraglutide is also evaluated as being weaker than that of semaglutide. However, the cost of Victoza and Saxenda is at least $500 (about 730,000 won) per month, which is half the price of Ozempic and Wegovy, both of which exceed $1,000 (about 1,450,000 won) per month. This is why many patients preferred Victoza and Saxenda over Ozempic and Wegovy.
Due to the high demand for liraglutide, it was added to the FDA's shortage list in July last year, before the patent expiration. Medications on this list can temporarily be produced and sold as generics by FDA-approved compounding pharmacies or small pharmaceutical companies. The ingredient semaglutide in Ozempic and Wegovy was also included on this list.
The FDA is prioritizing the review of generic drug applications for medications on this shortage list. This is expected to improve supply conditions and significantly enhance patients' access to the medications at reduced prices. The FDA anticipates that the official approval of the Victoza generic will stabilize the supply shortage situation.
Iilun Murphy, Director General of the FDA's Center for Drug Evaluation and Research, noted, "We are prioritizing the evaluation of generic drug applications for products on the shortage list to improve patient access. This approval of the generic form of liraglutide will enhance patient access to safe, effective, and high-quality generic medications."
However, experts believe that significant price reductions will take time. Aaron Kesselheim, a professor at Harvard Medical School, said on the 25th (local time) to CNN, "Usually, more than four generic medications must be launched on the market for prices to be expected to decrease by more than 50-60%."
Meanwhile, Novo Nordisk is investing in production facilities to prevent its two GLP-1 medications, liraglutide and semaglutide, from being included in the shortage list. This is important as several diabetes and obesity medications developed by Novo are sold as various combination therapies, aiming to stabilize supply and increase market share and revenue in the GLP-1 market. The diabetes treatment Ozempic from the semaglutide category was added to the shortage list in August 2022, and Wegovy was added in April this year.