Teva Brings First GLP-1 Generic for Weight problems, Targets Novo’s Saxenda

The FDA has signed off on the primary generic GLP-1 drug for weight reduction. Thursday, the regulator permitted Teva Prescribed drugs’ copycat model of Novo Nordisk’s Saxenda, which, like its branded counterpart, comprises the lively ingredient liraglutide.

Teva’s Saxenda generic is indicated for continual weight administration in adults who’re overweight or obese with at the very least one weight-related comorbidity, and in pediatric sufferers with weight problems who’re 12 years and older and have a physique weight of at the very least 60 kg.

Teva has additionally launched its liraglutide generic alongside its approval, based on the corporate’s announcement Thursday.

Liraglutide is a GLP-1 receptor agonist that, in some ways, is a predecessor to Novo’s blockbuster drug semaglutide. This forerunner remedy was first permitted in 2010 for the remedy of sort 2 diabetes, for which it carried the model title Victoza. Saxenda, which is similar compound as Victoza, adopted almost 5 years later when the FDA in December 2014 cleared it for weight reduction. In December 2024, Teva secured regulatory approval for a Victoza generic for sort 2 diabetes.

Since its preliminary approval in 2010, Novo’s liraglutide franchise has been a constant contributor to its earnings, with Saxenda and Victoza bringing in $1.08 billion and $860 million final yr, respectively. Nevertheless it has since been eclipsed by the semaglutide manufacturers Ozempic for sort 2 diabetes and Wegovy for weight problems.

Nonetheless, Teva’s generic approval on Thursday might pose extra issues for Novo’s enterprise, which up to now this yr has already been burdened by compounders consuming into Wegovy gross sales. Yr-to-date, the pharma’s shares have slid greater than 40%, with each buyers and analysts expressing skepticism relating to the corporate’s business execution for its semaglutide franchise.

Throughout Novo’s Q1 earnings name, as an example, BNP Paribas’ Peter Verdult questioned Novo’s insistence that compounders had been the issue. “Is it actually solely in regards to the compounders or do we’ve got to contemplate your nearest branded competitor doing a greater job?” he requested firm executives, referring to Eli Lilly and its personal weight reduction drug Zepbound.

Amid its shares droop, Novo in Might ousted its long-time CEO Lars Fruergaard Jørgensen, citing “latest market challenges” that the pharma had been going through. The corporate named his alternative—Maziar Mike Doustdar, beforehand Novo’s govt vp of inside operations—final month, whereas concurrently reducing its full-year gross sales outlook by 5%.