The war is on between compounding pharmacies making knockoff versions of popular weight loss drugs and pharma giants Novo Nordisk and Eli Lilly, who want to protect their right to sell their patented medications exclusively. 

In the middle is the FDA trying to referee the high-stakes and increasingly contentious battle.

Novo has fired the most recent shot, asking the U.S. regulator to prevent compounders from manufacturing copycat versions of its juggernaut diabetes and obesity treatments Ozempic and Wegovy, claiming the drugs are too complex to replicate safely. 

On Tuesday, the company nominated (PDF) semaglutide to be included on the FDA’s Demonstrable Difficulties for Compounding (DDC) lists.

“Semaglutide products belong on these lists due to the complexities associated with their formulations, delivery mechanisms, dosage forms, achievement of bioavailability, compounding processes, and physicochemical and analytical testing,” Novo wrote in its request.

The company has asked the FDA to convene an advisory committee to consider the matter.

“Novo Nordisk’s aim with this nomination is to ensure that patients receive only FDA-approved, safe, and effective semaglutide products,” the company said in an emailed statement.

Novo’s action comes in response to the increase in sales of compounded drugs in the U.S. In July, industry officials estimated that 2 million Americans were using compounded versions of Novo and Lilly’s blood sugar modulating drugs.

In a statement, Scott Brunner, the CEO of the Alliance for Pharmacy Compounding, referred to Novo’s action as “desperation.”

“Novo Nordisk is apparently so deeply concerned about patient safety that it’s taken them a whopping two-and-a-half years while their drug has been in shortage to conclude that the semaglutide (active pharmaceutical ingredient) is so demonstrably difficult for compounding pharmacies to prepare that FDA now needs to place it off-limits for compounding?” Brunner asked. “To me, this looks more like desperation and an attempt by Novo to protect its revenue stream than a serious scientific argument.”

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Brunner pointed out that the FDA’s Adverse Events Reporting System (FAERS) database shows that patient reports from those taking compounded and branded semaglutide are “remarkably similar.”

Compounding pharmacies have been allowed to make their knockoff versions of the drugs since the branded products were added to the FDA’s shortage list. Semaglutide was placed on the list in August of 2022, with Lilly’s tirzepatide following four months later. Last month, Novo said that it expected its shortage of Ozempic to continue through the end of the year

Earlier this month, when the FDA removed tirzepatide from the list, a compounding industry group fired off a lawsuit, claiming that the regulator made a “reckless and arbitrary decision—lacking any semblance of lawful process.” Four days later, the FDA said it was reviewing its decision to remove tirzepatide from the shortage list.

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For decades, the production of compounded drugs has mostly been conducted on a small scale to fill existing prescriptions. But with the outsized demand for Lilly’s and Novo’s drugs, it has become a big business, with spas and online sellers attracting customers with prices that undercut those for branded versions of the drugs.