FDA set to review Sandoz's generic GLP-1s
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The U.S. FDA has agreed to review two generic tirzepatide GLP-1s from Sandoz. If approved, these therapies could become some of the first affordable generics on the weight-loss and type-2 diabetes market, directly rivaling Eli Lilly’s Mounjaro and Zepbound.
The U.S. Food and Drug Administration has agreed to review Swiss generics drugmaker Sandoz's two generic tirzepatide GLP-1s that, if approved, would rival obesity drugs made by Eli Lilly.With Eli Lilly's tirzepatide patent running out in 2036 in the U.S., makers of alternative drugs are fighting for a share of the weight loss market.
Sandoz says its drugs would treat the same conditions, including type-2 diabetes as well as weight management, as Eli Lilly's Mounjaro and Zepbound."Sandoz tirzepatide could be one of the first generic tirzepatide products available for patients in the U.S. on market formation," the company said in a statement.
It is unclear how long the FDA review will take.Its website says it expects to decide on whether standard drugs are safe no more than 10 months after applications are received.Sandoz said in November it expected unbranded versions of Novo Nordisk's diabetes drug Ozempic in Canada to be launched by the end of June, as it aims to be one of the first in the market, but has yet to make any further announcement.
