UPDATE 1-Hybio's generic weight-loss drug set for FDA review
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SHANGHAI/BEIJING, June 30 (Reuters) - 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.
