Novo Nordisk NVO has appealed to the U.S. Food and Drug Administration (FDA) to halt the production of compounded versions of its drugs Wegovy and Ozempic by compounding pharmacies. These cheaper alternatives have been under scrutiny due to potential safety risks and lack of FDA approval.
What Happened: The Danish pharmaceutical giant lodged a request on Tuesday for the FDA to prohibit the production of unapproved versions of its weight loss drug Wegovy and diabetes treatment Ozempic, as reported by CNBC.
Novo Nordisk contends that the complexity of these medications makes it unsafe for them to be produced by other manufacturers. The FDA has not made a final decision on whether to ban compounded versions of semaglutide, the active ingredient in both drugs.
“Semaglutide products fit this description due to their inherent complexity and the potential dangers associated with attempting to compound them,” said the company in a statement, according to the report.
This is the latest in a series of actions by Novo Nordisk to combat the production of potentially harmful semaglutide copies, following 50 lawsuits filed against various clinics, compounding pharmacies, and manufacturers over the past year. The company is working to increase the supply of semaglutide to meet the high U.S. demand.
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Why It Matters: The demand for compounded versions of semaglutide has surged due to intermittent U.S. shortages of the branded drugs, which cost $1,000 per month before insurance and other rebates. Many health plans do not cover semaglutide for weight loss, making compounded versions a more affordable alternative.
In November 2023, Novo Nordisk sued Florida compounding pharmacies over impurities in their products claiming to contain semaglutide. In May this year, Australia banned compounded versions of weight-loss drugs like Novo Nordisk’s Ozempic due to safety concerns.
As the weight-loss drug market expands, companies like Hims & Hers Health, Inc. HIMS have found a niche by offering affordable alternatives to popular anti-obesity medications. However, concerns over the sustainability of this business model have grown as big pharmaceutical companies ramp up production to meet demand.
In October, Eli Lilly And Co. LLY also increased its legal campaign against compounding companies making and selling copycat versions of its blockbuster drugs for weight loss.
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This story was generated using Benzinga Neuro and edited by Shivdeep Dhaliwal
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