Novo Nordisk asks FDA to ban compounded Ozempic, Wegovy copies

Novo Nordisk on Tuesday asked the Food and Drug Administration to prevent compounding pharmacies from making unapproved and sometimes cheaper versions of its popular weight reduction injection Wegovy and diabetes treatment Ozempic, arguing that the medications are too complex for those manufacturers to make safely. 

The FDA still has to make a final decision on whether to bar compounded versions of semaglutide, the lively ingredient in Ozempic and Wegovy. In a press release, the agency said it’s reviewing the petition and can respond on to Novo Nordisk.

The move is Novo Nordisk’s latest try and crack down on potentially harmful copies of semaglutide after it filed 50 lawsuits against several clinics, compounding pharmacies and other manufacturers over the past yr. It comes because the Danish drugmaker tries to ramp up the availability of semaglutide to satisfy unprecedented demand within the U.S.

Patients have turned to compounded versions of semaglutide amid intermittent U.S. shortages of the branded drugs, which carry hefty price tags of $1,000 per thirty days before insurance and other rebates. Many health plans don’t cover semaglutide for weight reduction, making compounded versions a cheaper alternative.

Compounded medications are custom-made alternatives to branded drugs designed to satisfy a particular patient’s needs. When a brand-name medication is in shortage, compounding pharmacies can prepare copies of the drug in the event that they meet FDA requirements. 

The lively ingredient in Wegovy and Ozempic, semaglutide, has been in intermittent shortages over the past two years. The bottom dose of Wegovy is currently in brief supply, but all other doses of the drug and Ozempic are listed as available, based on the FDA’s drug shortage database. 

But Novo Nordisk late Tuesday nominated semaglutide to the FDA’s “Demonstrable Difficulties for Compounding” lists, which include complex drugs that compounders aren’t allowed to make, even during shortages, because they may potentially pose safety risks. 

“Semaglutide products fit this description because of their inherent complexity and the potential dangers related to attempting to compound them,” Novo Nordisk said in a press release. 

The Danish drugmaker cited several risks with compounded versions of semaglutide, including unknown impurities, incorrect dosage strengths and instances where a compounded product contained no semaglutide in any respect. 

“These drugs are inherently complex to compound safely, and the risks they pose to patient safety far outweigh any advantages,” Novo Nordisk said in a press release. The corporate said its “aim with this nomination is to be certain that patients receive only FDA-approved, protected, and effective semaglutide products.”

The FDA has previously warned concerning the risks of using compounded versions of so-called GLP-1s corresponding to semaglutide. That refers to a buzzy class of medicines that mimic hormones produced within the gut to tamp down an individual’s appetite and regulate their blood sugar. 

Earlier this month, the FDA said compounded versions of semaglutide and similar drugs may be dangerous for patients because they’re unapproved, meaning the agency doesn’t review their safety, effectiveness and quality before they’re put out out there. 

The FDA in August also said it had received reports of patients overdosing on compounded semaglutide because of errors corresponding to patients self-administering incorrect amounts of a treatment. 

Each Wegovy and Ozempic are under patent protection within the U.S. and abroad, and Novo Nordisk and its rival Eli Lilly don’t supply the lively ingredients of their drugs to outside groups. The businesses say that raises questions on what some manufacturers are selling and marketing to consumers.

Tirzepatide is the lively ingredient in Eli Lilly’s weight reduction injection Zepbound and diabetes treatment Mounjaro. 

Like Novo Nordisk, Eli Lilly has sued several weight reduction clinics, medical spas and compounding pharmacies across the U.S. over the past yr. 

Notably, the FDA took tirzepatide off its shortage list earlier in October after greater than a yr, whilst some pharmacies say they’re still struggling to replenish on the branded versions of that drug. A trade group representing some compounders sued the FDA, which led the agency to say it can reconsider its decision to remove tirzepatide from its shortage list.