Last update:November 14, 2024, 2:05 PM IST

Novo Nordisk, which makes weight loss drug Wegovy and diabetes drug Ozempic, has asked US authorities to stop making copies of the drugs because the semaglutide compound found in the drugs is in short supply in the US and pharmacies are making synthetic versions of them.

Clinical trials on Ozempic and Wegovy found that semaglutide can lead to significant weight loss in both people with and without type 2 diabetes. (Representative photo)

Millions of people have used weight loss drugs available in their country. Some of them also used alternatives to the popular drugs Wegovy and Ozempic from compounding pharmacies, which pose safety risks.

Recently, Novo Nordisk, the Danish pharmaceutical company that makes the weight loss drug Wegovy and the diabetes drug Ozempic, asked the US authorities to stop making copies of these drugs.

The US Food and Drug Administration (USFDA) allows compounding of human medicines, which means that licensed pharmacists or doctors can combine, mix or adjust the ingredients of a medicine to meet the needs of patients.

Novo Nordisk has filed at least 21 lawsuits nationwide against companies that make alleged copies of its drugs, company spokeswoman Brianna Kelley said, as quoted by CBS News.

The FDA has also warned of the potential danger of the compounds, and popular obesity drug groups have also warned patients against their use.

How does combining drugs work?

Drug compounding is a process that involves changing or combining ingredients in a drug.

Compounded medicines are useful for people with allergies to certain ingredients. They also help fill a supply gap during drug shortages (such as the one currently affecting many weight loss drugs).

The 2013 law created two classes of compounding pharmacies: the FDA regulates larger 503B compounders to the same standards as commercial drug companies, while 503A pharmacies make smaller batches of drugs and are largely overseen by state boards of pharmacy.

The 503A facilities also manufacture combined semaglutide and tirzepatide for hundreds of thousands of patients.

Semaglutide, which is found in the popular drugs Wegovy and Ozempic, is difficult to replicate accurately because of 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 has been in short supply in the US for much of this year. Together, compounding pharmacies may account for up to 30% of semaglutide sold in the US.

The FDA-approved version of semaglutide includes specific components — such as fatty acid — that determine how long it stays effective in the body, and synthetic versions may not have similar results. Although it hasn’t been subjected to the same rigorous testing and oversight.

Clinical trials on Ozempic and Wegovy found that semaglutide can lead to significant weight loss in both people with and without type 2 diabetes.

About 30 percent of them lost 20 percent of their body weight—which is comparable to the amount of weight loss seen after weight loss surgery.

What are the risks associated 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 properly sanitized.

According to Novo Nordisk, in March 2022 the FDA found sterility issues at a compounding pharmacy that had five sterility failures with injectable drugs in one year and released products before confirming they were sterile. More than 15,000 injectable units of semaglutide were recalled, the company said — and another recall followed in August 2023 for the same reasons, according to Indian Express report.

According to Novo Nordisk, semaglutide is a temperature-sensitive drug and storing it at temperatures above 30 degrees Celsius may compromise its stability.

What does Novo Nordisk say?

In its statement, the Danish drugmaker asked the FDA to consider putting semaglutide on a list of drugs that, while in short supply, are too complex to copy.

Novo said compounded versions of Wegovy are being sold in incorrect doses, have been found to contain unknown impurities and have been linked to nearly 400 serious adverse events since 2018.

Novo said in a statement that it wants to ensure that patients receive only FDA-approved, safe and effective semaglutide products.

The Alliance for Pharmacy Compounding, which represents pharmacists and compounding technicians, said in a statement that Novo was “mistaking the fact that the semaglutide molecule is difficult to produce … with the relative simplicity of compounding it,” as quoted by Reuters.

Chief Financial Officer Karsten Munk Knudsen said last week that reports linked at least 10 deaths and more than 100 hospitalizations to the combined versions of Wegovy and Ozempic.

The Danish drugmaker and rival Eli Lilly have jointly sued dozens of US medical spas, weight loss clinics, pharmacies and online sellers for selling products they claim contain the active ingredients in their obesity drugs.