Novo Nordisk seeks FDA's approval to prohibit compounding pharmacies from producing Ozempic and Wegovy copies.

• Novo Nordisk requested the FDA to prohibit compounding pharmacies from producing cheaper versions of its widely used weight loss injection Wegovy and diabetes medication Ozempic.
• The Danish drugmaker claims that the medications are too complex for manufacturers to produce safely.
• The FDA has not yet made a final decision on whether to ban unapproved versions of semaglutide, the active ingredient in Ozempic and Wegovy.

The Food and Drug Administration requested on Tuesday that compounding pharmacies be prohibited from producing unauthorized and less expensive versions of Wegovy, a popular weight loss injection, and Ozempic, a diabetes treatment, due to the complexity of these medications and the potential risks associated with their production.

Novo Nordisk's petition to bar compounded versions of semaglutide is still under review by the FDA, and the agency will respond directly to the company.

Novo Nordisk is taking legal action against unauthorized manufacturers of semaglutide in an effort to protect consumers from potentially harmful copies of the drug. This move comes as the Danish drugmaker works to increase production to meet rising demand for the medication in the U.S.

Amid U.S. shortages of branded semaglutide, patients have turned to compounded versions of the drug, which are more affordable due to their lower price tags of around $100 per month before insurance and other rebates. Many health plans don't cover semaglutide for weight loss, making compounded versions a more affordable alternative.

Custom-made alternatives to branded drugs, known as compounded medications, are designed to meet specific patient needs. In the event of a shortage of a brand-name medication, compounding pharmacies can prepare copies of the drug if they adhere to FDA requirements.

Semaglutide, the active ingredient in Wegovy and Ozempic, has been experiencing intermittent shortages for the past two years. Currently, the lowest dose of Wegovy is in short supply, but all other doses of the drug and Ozempic are listed as available, according to the FDA's drug shortage database.

On Tuesday, Novo Nordisk submitted semaglutide to the FDA's "Demonstrable Difficulties for Compounding" lists, which prohibit compounders from making complex drugs during shortages due to potential safety risks.

Novo Nordisk stated that Semaglutide products fit this description because of their inherent complexity and the potential dangers associated with attempting to compound them.

Several risks associated with compounded versions of semaglutide were highlighted by the Danish drugmaker, including the presence of unknown impurities, incorrect dosage strengths, and instances where a compounded product contained no semaglutide at all.

"Novo Nordisk stated that these drugs are difficult to compound safely and the risks they pose to patient safety are greater than any benefits. The company's goal with this nomination is to ensure that patients receive FDA-approved, safe, and effective semaglutide products."

The FDA has previously cautioned about the dangers of using compounded versions of GLP-1s, such as semaglutide, which are a popular class of medications that mimic gut hormones to suppress appetite and manage blood sugar levels.

The FDA has warned that unapproved compounded versions of semaglutide and similar drugs can pose risks to patients because the agency does not assess their safety, effectiveness, and quality before they are released in the market.

In August, the FDA stated that it had received reports of patients overdosing on compounded semaglutide due to errors such as patients self-administering incorrect amounts of a treatment.

The patent protection of Wegovy and Ozempic in the U.S. and abroad raises concerns about the authenticity of the active ingredients in drugs sold by Novo Nordisk and its competitors.

Eli Lilly's weight loss injection Zepbound and diabetes treatment Mounjaro contain the active ingredient tirzepatide.

Eli Lilly has filed lawsuits against numerous weight loss clinics, medical spas, and compounding pharmacies in the U.S. over the past year, similar to what Novo Nordisk has done.

The FDA removed tirzepatide from its shortage list in October, but some pharmacies still struggle to stock branded versions of the drug. A trade group representing compounders sued the FDA, prompting the agency to reconsider its decision.