Novo joins Lilly in asking FDA for ban on GLP-1 compounding

Novo Nordisk has asked the FDA to stop compounding pharmacies making cheaper versions of its semaglutide-based therapies for obesity and diabetes, saying the drug is too complex to be made safely by these manufacturers.

Under US law, compounding pharmacies can make and sell patent-protected drugs that are on the FDA's shortages list in limited amounts, and have been reaping the rewards of supplying versions of Novo Nordisk's obesity drug Wegovy and Ozempic for diabetes, which are both based on the GLP-1 receptor agonist.

Wegovy and Ozempic remain on the FDA's shortages list, despite strenuous efforts by Novo Nordisk to ramp up its production capacity for semaglutide. The Danish drugmaker has asked the FDA to move semaglutide onto the 'Demonstrable Difficulties for Compounding' list of drugs that – while in limited supply – are considered too complicated to be made by compounders.

The request follows a similar move by Eli Lilly, which has asked for a ban on other parties making copies of its tirzepatide-based therapies Mounjaro for diabetes and Zepbound for obesity, as well as dozens of legal challenges from Novo Nordisk against medical spas, weight loss clinics, pharmacies, and other companies that it accuses of unlawfully making semaglutide.

The company has claimed that compounded semaglutide with incorrect dosages and 'known and unknown' impurities have been given to patients in the US, saying earlier this year that it was aware of more than 400 adverse events associated with the drugs. Of these, more than 300 were serious and almost 100 required hospitalisation, with seven deaths.

The company said in a statement that it wants patients in the US to only have access to "FDA-approved, safe, and effective" semaglutide products, adding: "These drugs are inherently complex to compound safely, and the risks they pose to patient safety far outweigh any benefits."

The Alliance for Pharmacy Compounding (APC), a trade organisation representing the compounding industry, has claimed that Novo Nordisk is "confusing the fact that the semaglutide molecule is demonstrably difficult to manufacture […] with the relative simplicity of compounding with it," according to Reuters.

Earlier this month, the FDA put out a statement saying that it, too, was concerned about patients and healthcare professionals turning to unapproved versions of GLP-1 drugs as an option for weight loss, saying: "This can be risky for patients, as unapproved versions do not undergo FDA's review for safety, effectiveness, and quality before they are marketed."

Tirzepatide was removed from the shortages list a few weeks ago, leading to restrictions on the sale of compounded versions. However, the FDA has launched a review to check if the shortages have actually been resolved, after it was sued by the Outsourcing Facilities Association (OFAC), another trade body.

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