-- (Updates with Lilly's comment in the third paragraph.)
The US Food and Drug Administration said Thursday it is proposing to exclude tirzepatide, semaglutide and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound the drugs from bulk substances.
Eli Lilly (LLY) manufactures tirzepatide, marketed as Mounjaro for type 2 diabetes and Zepbound for chronic weight management. Novo Nordisk (NVO) manufactures semaglutide, marketed as Ozempic for type 2 diabetes and Wegovy for chronic weight management, and liraglutide, under the brand name Victoza for type 2 diabetes and Saxenda for chronic weight management.
In an emailed statement to, Lilly said it is "pleased FDA has confirmed there is no clinical need for compounded tirzepatide. That means there is no basis for compounders to make tirzepatide knockoffs. Lilly will continue working to protect patients from the risks associated with unapproved drugs prescribed without a medical need."
Under federal law, outsourcing facilities generally cannot compound drugs from bulk substances unless the ingredient appears on the 503B bulks list or the compounded drug is on the FDA's drug-shortage list at the time of compounding, distribution and dispensing, the agency said.
The FDA is accepting public comments on the proposal through June 29.
Novo Nordisk didn't immediately reply to a request for comment from.
Lilly shares jumped 9.8% in Thursday trading, and Novo Nordisk gained 5.7%
Price: $934.57, Change: $+83.36, Percent Change: +9.79%