Why Copies Of ‘Magic’ Weight-Loss Drugs Are A Concern For Big Pharma | Explained – News18
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Novo Nordisk, which manufactures weight-loss drug Wegovy and diabetes medication Ozempic, has asked the US authorities to stop making copies of these drugs as semaglutide compound found in the medicines is in shortage in the US and pharmacies are making synthetic versions of them
Clinical trials on Ozempic and Wegovy have found that semaglutide can lead to significant weight loss in people both with and without type 2 diabetes. (Representational Photo)
Millions of people have been using weight-loss drugs available in their country. Some of them have also been using alternatives to the popular Wegovy and Ozempic medicines from compounding pharmacies, which pose safety risk.
Recently, Novo Nordisk, the Danish pharmaceutical company, which manufactures weight-loss drug Wegovy and diabetes medication Ozempic, has asked the US authorities to stop making copies of these drugs.
US Food and Drug Administration (USFDA) allows human drug compounding, which means licensed pharmacists or physicians can combine, mix or adjust the ingredients of a medicine to meet patients’ needs.
Novo Nordisk has filed at least 21 lawsuits nationwide against companies making purported copies of its drugs, said Brianna Kelley, a spokesperson for the company, quoted by CBS News.
The FDA too has cautioned about the potential danger of the compounds, and popular obesity medicine groups have also warned patients against their use.
How Does Compounding Of Drugs Work?
Compounding of drugs is a process that involves changing or combining ingredients in a medication.
Compounded drugs are helpful for people with allergies to certain ingredients. They also help fill a gap in supply during drug shortages (like the one currently affecting many weight-loss drugs).
The 2013 law created two classes of compounding pharmacies: The FDA regulates the larger 503B compounders with standards like commercial drug companies, while 503A pharmacies make smaller lots of drugs and are largely overseen by state boards of pharmacy.
The 503A facilities are also producing compounded semaglutide and tirzepatide for hundreds of thousands of patients.
Semaglutide, which is found in popular drugs Wegovy and Ozempic, is hard to replicate accurately due to its complex structure, Novo Nordisk said. The drug is manufactured using yeast and DNA technology, which gives it specific properties essential for its performance and safety.
Semaglutide is in shortage in the US for much of this year. Together, the compounding pharmacies may account for up to 30% of the semaglutide sold in the US.
The FDA-approved version of semaglutide includes specific components — such as the fatty acid — that determine how long it stays effective in the body, and synthetic versions may not perform similarly. Although it has not been subjected to the same rigorous testing and oversight.
Clinical trials on Ozempic and Wegovy have found that semaglutide can lead to significant weight loss in people both with and without type 2 diabetes.
About 30% of them lost 20% of their body weight — which is comparable to the amount of weight loss seen after weight loss surgery.
What Are The Risks With Semaglutide?
Due to the requirements of specialized facilities and equipment, the risk of contamination is a major concern. Contamination usually occurs if the equipment is not sanitized properly.
According to Novo Nordisk, in March 2022, the FDA found issues with sterility at a compounding pharmacy that had had five sterility failures with injectable drugs in one year, and had released products before confirming they were sterile. More than 15,000 injectable semaglutide units were recalled, the company said — and another recall had followed in August 2023 for the same reasons, as per The Indian Express report.
According to Novo Nordisk, semaglutide is a temperature-sensitive drug and storing it at temperatures higher than 30 degrees Celsius can compromise its stability.
What Is Novo Nordisk Saying?
In its submission, the Danish drugmaker asked the FDA to consider placing semaglutide on a list of drugs that, even though they are in shortage, are too complex to be copied.
Novo said compounded versions of Wegovy are being sold in incorrect dosage strengths, have been found to contain unknown impurities, and have been linked to nearly 400 serious adverse events since 2018.
Novo said in a statement it wanted to ensure patients only received FDA-approved, safe, and effective semaglutide products.
The Alliance for Pharmacy Compounding, which represents compounding pharmacists and technicians, said in its statement that Novo was “confusing the fact that the semaglutide molecule is demonstrably difficult to manufacture … with the relative simplicity of compounding with it,” as quoted by Reuters.
Chief Financial Officer Karsten Munk Knudsen had said last week that reports had linked at least 10 deaths and more than 100 hospitalisations to compounded versions of Wegovy and Ozempic.
The Danish drugmaker and rival Eli Lilly have together sued dozens of medical spas, weight-loss clinics, compounding pharmacies and online vendors in the US for selling products claiming to contain the active ingredients in their obesity drugs.
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