Teva brings first generic GLP-1 to US market with Saxenda copycat approval
Generics firm Teva Pharmaceutical has obtained approval from the US Meals and Drug Administration (FDA) for its generic referencing Novo Nordisk’s earlier technology of injectable weight reduction drug, Saxenda (liraglutide).
This marks the primary time a generic glucagon-like peptide-1 receptor agonist (GLP-1RA) treatment has been permitted for weight reduction within the US.
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Teva’s subcutaneous treatment can now be administered in grownup sufferers who’re chubby or overweight and have weight-related comorbidities. It’s also appropriate for overweight sufferers aged between 12 and 17 years who weigh greater than 60kg.
This marks Teva’s fifth first-to-market entry for a generic product this 12 months, in accordance with SVP and head of US industrial generics Ernie Richardsen.
Teva’s Saxenda generic approval comes amid the monumental rise in GLP-1RA gross sales, which have seen next-generation medication such Eli Lilly’s Zepbound (tirzepatide) and Novo Nordisk’s Wegovy (semglutide) earn $11.3bn and $13.4bn for the businesses, respectively, in 2024. These gross sales cemented their place within the high ten best-selling medication of the 12 months.
Nonetheless, in releasing the longer-lasting and more practical Wegovy, Novo’s Saxenda has dwindled in market share, with analysts at GlobalData, dad or mum firm of Pharmaceutical Know-how, forecasting that the drug’s gross sales will plummet to simply $135m in 2031 – down 91% from $1.5bn peak gross sales in 2022.
The looming potential introduction of Lilly and Nordisk’s weight reduction tablets, particularly orfoglipron and semaglutide, may additional exacerbate Saxenda’s declining gross sales, with each pharma firms racing to acquire FDA approval for his or her variations.
Nonetheless, GlobalData pharma analyst Costanza Alciati famous that generics getting into the GLP-1RA market might encounter a special destiny than branded Saxenda, as they’re more likely to seize “a giant a part of the affected person share”.
Aliciati stated: “Price of remedy is a giant unmet want within the weight problems house, as branded medication on this indication are costly – usually burdening each sufferers and healthcare techniques.
“Not solely may a liraglutide generic enhance the affected person inhabitants in a position to entry GLP-1Ras, however it may additionally enable sufferers to modify from branded medication to an older generic if a lower-efficacy product is enough.”
Although it’s but to be seen if liraglutide will turn into a beneficial selection for prescribers and sufferers alike, Aliciati acknowledged that the generic approval will probably haven’t any affect on gross sales of Wegovy and Zepbound, as “some sufferers will nonetheless require greater weight reduction efficacy than what is obtainable by liraglutide”.
Transferring ahead, GLP-1RA gross sales will probably stay on a steep upward trajectory, with analysts at GlobalData, dad or mum firm of Pharmaceutical Know-how, forecasting that the drug class can be value $125bn throughout the seven main markets (7MM: US, France, Germany, Italy, Spain, UK and Japan) by 2033.
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