In December 2024, Teva also secured FDA approval for the other liraglutide brand Victoza, indicated for type 2 diabetes.
The FDA has signed off on the first generic GLP-1 drug for weight loss. Thursday, the regulator approved Teva Pharmaceuticals’ copycat version of Novo Nordisk’s Saxenda, which, like its branded counterpart, contains the active ingredient liraglutide.
Teva’s Saxenda generic is indicated for chronic weight management in adults who are obese or overweight with at least one weight-related comorbidity, and in pediatric patients with obesity who are 12 years and older and have a body weight of at least 60 kg.
Teva has also launched its liraglutide generic alongside its approval, according to the company’s announcement Thursday.
Liraglutide is a GLP-1 receptor agonist that, in many ways, is a predecessor to Novo’s blockbuster drug semaglutide. This forerunner therapy was first approved in 2010 for the treatment of type 2 diabetes, for which it carried the brand name Victoza. Saxenda, which is the same compound as Victoza, followed nearly five years later when the FDA in December 2014 cleared it for weight loss. In December 2024, Teva secured regulatory approval for a Victoza generic for type 2 diabetes.
Since its initial approval in 2010, Novo’s liraglutide franchise has been a consistent contributor to its earnings, with Saxenda and Victoza bringing in $1.08 billion and $860 million last year, respectively. But it has since been eclipsed by the semaglutide brands Ozempic for type 2 diabetes and Wegovy for obesity.
Still, Teva’s generic approval on Thursday could pose additional problems for Novo’s business, which so far this year has already been burdened by compounders eating into Wegovy sales. Year-to-date, the pharma’s shares have slid more than 40%, with both investors and analysts expressing skepticism regarding the company’s commercial execution for its semaglutide franchise.
During Novo’s Q1 earnings call, for instance, BNP Paribas’ Peter Verdult questioned Novo’s insistence that compounders were the problem. “Is it really only about the compounders or do we have to consider your nearest branded competitor doing a better job?” he asked company executives, referring to Eli Lilly and its own weight loss drug Zepbound.
Amid its shares slump, Novo in May ousted its long-time CEO Lars Fruergaard Jørgensen, citing “recent market challenges” that the pharma had been facing. The company named his replacement—Maziar Mike Doustdar, previously Novo’s executive vice president of internal operations—last month, while simultaneously cutting its full-year sales outlook by 5%.
