The pitch is all over social media and is irresistible to many people who want to lose weight: Get a copycat version of an expensive, hard-to-find drug like Ozempic or Mounjaro at a fraction of the price.
But the company’s boom in the off-label version of the blockbuster drug, which stimulates the GLP-1 hormone and curbs hunger, has made consumers wonder if it’s worth trying. Here’s what you need to know.
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What is the difference between branded drugs and cheap imitations sold online?
Novo Nordisk, which makes Ozempic and Wegovy (active ingredient: semaglutide), and Eli Lilly, which makes Mounjaro and Zepbound (tirzepatide), have gone through the FDA’s tough process to get regulatory approval for the drugs. These are GLP-1, which includes safety studies. and they are efficient and control the production facilities. The FDA has not approved the generic version.
However, the two drug manufacturers were unable to keep up with the seemingly unreasonable demand for the product, leading the FDA to officially declare the drug in short supply. That designation opened the door for specialty pharmacies to produce copies of blockbuster drugs, which they are legally allowed to do when there are not enough FDA-approved drugs that meet certain criteria. Combination GLP-1 drugs require a prescription.
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What is a pharmacy and why are GLP-1 drugs cheaper?
Traditional compounding pharmacies prepare prescription medications to meet individual patient needs, such as mixing liquids for people who cannot swallow pills. They are licensed and supervised by the government. The FDA monitors their practices but does not approve their products.
When it comes to weight loss drugs, the pharmacy has lower prices than Novo Nordisk and Eli Lilly, which spent billions of dollars to research and develop the drug and meet the FDA’s quality standards.
For its raw materials, pharmacies turn to contract manufacturers – mainly overseas – who are registered with the FDA as manufacturers of semaglutide and tirzepatide. Converting the raw active ingredient from powder form to an injectable solution does not require advanced chemistry, pharmacists say, allowing pharmacies to offer GLP-1 drugs to healthcare providers for Two hundred dollars a month or less.
Some research suggests that the brand manufacturers, meanwhile, mark the price advantage. A study conducted by Yale University earlier this year found that injectable semaglutide can be manufactured for less than $5 per month, compared to the list price of Ozempic. $968.52 for a month’s supply. Novo Nordisk said in a statement that the analysis did not take into account research and development costs or the construction of "the world’s first manufacturing infrastructure".
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Are weight loss pills safe?
With extensive supply chains and multiple vendors making sterile, injectable drugs, there are additional safety risks with pharmacy-made drugs. How much is up for debate.
The FDA says that compounded drugs are generally not as safe as drugs that have been reviewed by the agency. Between August 2021 and mid-July, it reviewed 288 reports of patients with adverse reactions to combined semaglutide and 108 such reports to tirzepatide, a spokesperson said. These are just a few of the tens of thousands of incident reports people have submitted for all kinds of drugs, including brand-name versions, with well-documented side effects.
Novo Nordisk and Eli Lilly argued in court that the public statement that they mixed the GLP-1 drug was not safe, saying that their own tests had found impurities in the version. mixed with his medicine.
"The prevalence of companies claiming to offer combined tirzepatide is a safety concern," Lilly said in a statement, adding that such products have not received FDA approval and have not been shown to be safe or effective. Novo Nordisk cited unsanitary deficiencies with compounded semaglutide from six pharmacies it sued, saying it could pose a risk to patient safety.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said the companies' allegations are unproven. "Look, FDA-approved drugs should be the first line of treatment," he said. Because drugmakers can’t meet demand for their products, pharmacies are "saving the day" by filling the gap, Brunner added.
Andrew Kraftson, director of the weight management program at the University of Michigan, said patients ask him about combined semaglutide, but he won’t prescribe it.
"There are a lot of unanswered questions," Kraftson said. "People just inject it into their body with a lot of confidence and hope."
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What can I do to reduce the risk of combined GLP-1 drugs?
For those who are inclined to follow a combination GLP-1 drug despite the potential risks, here are a few things to consider:
– Identification of the health service provider who will provide it. This allows you to review the provider’s experience and check their regulatory history in the state in which they are licensed.
-Check which pharmacy the prescriber or service uses, then search the website of the board of pharmacy or the FDA to see if the administration has taken action.
– Ask the supplier or the pharmacy to put together a certificate of analysis that shows the results of testing the raw materials.
=Some websites used to sell "semaglutide sodium." The FDA does not consider semaglutide sodium to be the same substance as approved drugs such as Ozempic and Wegovy. Instead, he said the sodium version should not be used to make a copy of the drug for impotence and "has not been shown to be safe and effective."
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What is it like to take combined GLP-1 drugs?
For all versions of the medicine, the process begins with a visit – in person or online – to a health care professional, who writes a prescription and orders the medicine.
Telehealth companies that provide compounded medications often send the medication to the patient’s home, usually in a vial with a syringe, as opposed to the brand-name version that comes in a pre-filled injection pen.
Jess Winfrey, 36, who has polycystic ovary syndrome and lives in Dallas, started taking a combination of semaglutide and later tirzepatide last October because she didn’t think her insurance would cover the weight-loss drug. . Winfrey said she received prescriptions from three telehealth companies — in one case after filling out a questionnaire without talking to a doctor.
Before trying GLP-1 pills, Winfrey had never shot herself before. "It took me 30 minutes because I kept pulling the medicine out of the syringe and pushing it back, because I didn’t know if I was doing it right," he said. "By the end of it I had beads of sweat on my forehead because I was so scared."
But Winfrey said she quickly got over her fears. Now a paid promoter of weight loss drugs, she streams her "injection day" live on TikTok to help others overcome their anxiety.
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How long will it take for FDA designation to allow combination GLP-1 drugs?
Demand is so great that shortages are expected to persist into next year, but even executives at Novo Nordisk and Eli Lilly are reluctant to give firm predictions. The FDA said it would resolve the shortage once manufacturers can meet "national historical requirements," and the agency confirmed it has additional "safety stock" and that all orders have been filled.
Eric Tichy, who manages the drug supply chain at the Mayo Clinic in Rochester, Minn., said the injectable GLP-1 drug was the "number one refilled drug" for the hospital system but has improved dramatically. deficit in the last six months. .
FDA data show limited efficacy for two doses of Mounjaro and Zepbound, and for three lower doses of Wegovy. Eli Lilly said it is on track to ramp up production of its tirzepatide-based drug in the second half of this year, although executives said shortages could continue into next year. Novo Nordisk said it cannot estimate when all doses of Wegovy will be available.
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Will cheap GLP-1 drugs take off once shortages are resolved?
Compounding pharmacies that make copies of FDA-approved GLP-1 drugs must stop when they are no longer available. This means that some people who pay a few hundred dollars a month may see a significant increase in the cost of branded injections.
Still, Hims and Hers, a publicly traded telecommunications company, is betting that it will be able to sell a combination GLP-1 drug in the future, though analysts aren’t sure.
"The company’s ability to sell semaglutide once the shortage ends remains uncertain," Leerink Partners analyst Michael Cherny wrote in a research note in June. Hims and Hers have not directly discussed their plans for when the deficit ends.
There may be other ways to keep compounded drugs on the market after the shortage ends. For example, many pharmacies add vitamin B-12 to GLP-1 medications. If it made a difference to patients' health, a pharmacy could argue that it was more than a copy of a brand-name drug, said Robin Feldman, a professor at the University of California College of Medicine. of the Law in San Francisco and is an expert in pharmaceutical law. .
"However, GLP-1 drugs are the new gold rush," he said. "In uncharted territory, one should be cautious about making predictions."
Novo Nordisk’s patent for semaglutide expires in 2032, while Eli Lilly’s patent for tirzepatide expires in 2036. The company also holds other patents on the drug, and it may take longer to bring the generic version to market.
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