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FDA set to review Sandoz’s generic GLP-1s

By Thomson Reuters Jun 29, 2026 | 4:33 AM

ZURICH, June 29 (Reuters) – 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.

(Reporting by Marleen Kaesebier in Zurich; editing by ​Barbara Lewis)