Cheaper copycat versions of blockbuster weight loss drugs are flooding the market.
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Off-brand weight loss drugs containing the same active ingredients as Wegovy and Zepbound seem to be everywhere. Ads for the much cheaper alternatives are popping up on Instagram, in the subway and on TV.
But there are rules about when these copycats of brand-name drugs are allowed — and things could change once the original versions made by Novo Nordisk and Eli Lilly are no longer in short supply. The companies are ramping up their manufacturing now to meet skyrocketing demand.
Here’s what you need to know.
The off-brand drugs aren’t generics
The legal copycats are compounded drugs. They’re prepared by pharmacists using ingredients bought from suppliers registered with the Food and Drug Administration. In this case, pharmacies are buying semaglutide, the active ingredient in Wegovy and Ozempic, and tirzepatide, the active ingredient in Zepbound; preparing it for consumer use; and then offering it through telehealth websites or med spas.
Consumers still need prescriptions for the drugs. Telehealth companies typically offer an evaluation from a health care provider and a subscription to receive the medicine, if it’s warranted.
One big selling point: The compounded drugs cost a lot less. Hims, one of the newer providers, says a month’s supply of its semaglutide starts at $199, including online health consultations, compared with around $1,300 for Wegovy alone.
Compounded drugs don’t go through the FDA’s review process like generics do. The pharmacies themselves are mainly regulated by state boards of pharmacy, not the FDA. Looser regulation means there is more potential for problems with quality and safety.
Typically, compounded drugs are made for patients who aren’t served by existing FDA-approved medicines. For example, if someone needed a drug but was allergic to its preservative, a compounding pharmacist could prepare a version without that preservative.
But according to FDA regulations, compounding pharmacies are usually not allowed to prepare what is “essentially a copy” of an existing FDA approved drug. But there’s an exception.
Yes, it’s legal
If the FDA-approved drug isn’t available or is in short supply, the compounding pharmacies can step in.
That’s what’s happening now. The demand for these drugs grew so fast that the brand-name manufacturers can’t keep up.
While compounding is legal and part of the health care system, pharmacists who do it have a lot of rules to follow.
“Compounding pharmacies have to tiptoe carefully around intellectual property laws and FDA regulations,” says Robin Feldman, a law professor at the University of California. “But there are circuitous paths they can go through.”
In the meantime, the original drug companies are investing billions of dollars to increase production and are aiming to end the shortages within the next year or so.
An end to the shortages could upend compounding
Gail Bormel, acting director of the FDA’s Office of Compounding, says she can’t predict exactly what will happen when. But, she says, things would need to change when shortages end for brand names like Wegovy.
“Once the drug shortage is resolved … then they would no longer be able to produce and distribute essentially a copy of an FDA-approved drug,” says Bormel.
For larger compounding organizations called outsourcing facilities, they wouldn’t be able to make copies anymore. For smaller ones, they wouldn’t be able to make copies more than four times in one month.
However, compounders could make therapeutic tweaks to their versions of the popular drugs, says Feldman, the UC Law professor. Maybe they would add vitamin B12 or another vitamin, as many compounders are already doing, and the FDA would decide that means the compounded drugs are no longer copies.
The original manufacturers are fighting back
Novo Nordisk and Eli Lilly have already sued a few of these compounding companies over things like using their brand names in marketing materials.
They’ve also sued over impurities found in compounded products which could tarnish their drugs’ good name as people conflate the brand and the compounded version.
To be sure, there are risks associated with compounded drugs, including incorrect doses and contamination if they aren’t prepared properly. A contaminated drug could cause a serious reaction, and a drug containing too little of the active ingredient could be ineffective.
Feldman says she expects brand-name drugmakers to shift their legal fight to patent infringement as the shortages end.
The drugmakers, she says, spent a lot of time and money to bring these drugs to market and will want to assert their intellectual property claims and regain market share.
Semaglutide compounders may adapt
Despite reaching out for comment to more than a dozen online telehealth companies advertising compounded semaglutide and tirzepatide for sale, NPR only heard back from two.
Hims, a telehealth website, that started offering discounted compounded semaglutide in May and has said it specifically uses the larger types of facilities that the FDA says would be barred from making copies once the brand-name shortages end. The company didn’t offer specifics on how its semaglutide business would change after a shortage, but a spokesperson wrote in an email that the company plans to continue offering “personalized care.”
Ro, another telehealth website, offered no details about its plans. “We are committed to providing our patients the best treatments available and continually evaluate potential treatment options,” a spokesperson wrote in an email.
The Alliance for Pharmacy Compounding, the trade group for pharmacy compounders, says that an end to the name brand shortages would mean changes for compounding pharmacists.
However, there are pathways to continue preparing tweaked versions of semaglutide under federal law “when a prescriber judges that [a] particular compounded formula is not available commercially and achieves a clinical difference for the patient,” says the group’s CEO, Scott Brunner. “But that will be for providers to determine and prescribe, not pharmacists.”
