UPDATE 1-Hybio's generic weight-loss drug set for FDA review

Eli Lilly and Company

Eli Lilly and Company

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- The U.S. Food and Drug Administration has agreed to review Chinese generics drugmaker Hybio Pharmaceutical's 300199.SZ two experimental generic tirzepatide GLP-1s that, if approved, would rival obesity and diabetes drugs made by Eli Lilly LLY.N.

  • Eli Lilly's U.S. patent for tirzepatide, the active ingredient in its Mounjaro drug for patients with type II diabetes and Zepbound for obesity, expires in 2036.

  • Generic drugmakers including Hybio and Sandoz SDZ.S are fighting for a share of the booming weight-loss market.

  • Hybio says its drugs are for weight management and patients with type II diabetes.

  • Whether the company ultimately secures first-generic status remains subject to FDA final approval, it said in a stock exchange filing on Tuesday.

  • It is unclear how long the FDA review will take.

  • The FDA website says it expects to decide on whether standard drugs are safe no more than 10 months after applications are received.

  • The FDA has also agreed to review Sandoz's generics, Reuters reported on Monday.

  • Analysts expect the market to generate about $100 billion in annual sales globally over the next decade.