Cheap copycat types of weight loss drugs abound in the market.
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Inactive weight loss drugs with active ingredients similar to Wegovy and Zepbound seem to be everywhere. Ads for cheaper alternatives are popping up on Instagram, on the subway and on TV.
But there are rules about when these brand-name drug copies are allowed — and things could change once the original versions made by Novo Nordisk and Eli Lilly run out. Companies are increasing their production now to meet the rising demand.
Here’s what you need to know.
Generic drugs are not generics
Legal copies are compounded drugs. They are prepared by pharmacists using ingredients purchased from vendors registered with the Food and Drug Administration. In this case, pharmacies buy semaglutide, the active ingredient in Wegovy and Ozempic, and tirzepatide, the active ingredient in Zepbound; preparing it for consumer use; then offer it via telehealth networks or med spas.
Consumers still need prescriptions. Telephone companies often provide a diagnosis from a health care provider and a prescription to receive medication, if needed.
One big selling point: Compounded drugs cost a lot less. Hims, one of the new providers, said a month’s supply of its semaglutide starts at $199, including online health consultations, compared to about $1,300 for Wegovy alone.
Compounded drugs do not go through the same FDA review process as generics do. Pharmacies themselves are largely regulated by state boards of pharmacy, not the FDA. Lax management means that there are more opportunities for quality and safety problems.
Typically, combination medications are designed for patients who are not prescribed existing FDA-approved medications. For example, if someone needed a drug but was allergic to its ingredient, the compounding pharmacist could prepare a version without the ingredient.
But according to FDA regulations, compounding drugs are generally not allowed to prepare what is a “copy” of a drug already approved by the FDA. But there is an exception.
Yes, it is legal
If an FDA-approved drug is not available or in short supply, compounding pharmacies can step in.
That is what is happening now. The demand for these drugs increased so quickly that the brand manufacturers could not keep up.
Although compounding is legal and part of the health system, pharmacists who perform it have many rules to follow.
Robin Feldman, a law professor at the University of California, says: “Combination drugs have to look carefully at the laws of intellectual property and the rules of the FDA.” But there are detours that they can go through.
Meanwhile, the original drug companies are investing billions of dollars to increase production and aim to eliminate the shortage within the next year or so.
Ending deficits can lead to growth
Gail Bormel, acting director of the FDA’s Office of Compounding, said she can’t predict when that will happen. But, he says, things will need to change when the shortage ends for brands like Wegovy.
“Once the drug shortage is resolved … then they will no longer be able to produce and distribute a copy of the FDA-approved drug,” says Bormel.
For large conglomerates called outsourcing services, they will no longer be able to make copies. For the younger ones, they would not be able to make more than four copies in one month.
However, compounders can make therapeutic tweaks to their versions of popular drugs, says Feldman, the UC Law professor. Maybe they can add vitamin B12 or another vitamin, as many compounders already do, and the FDA will decide that means the compounded drug is no longer counterfeit.
Early adopters are still struggling
Novo Nordisk and Eli Lilly have already sued several of these companies for things like using their names in marketing materials.
They also charge that impurities found in compounded products can damage the good name of their drugs when people associate the name with the compounded brand.
Of course, there are risks associated with compounded drugs, including wrong dosages and infections if they are not prepared properly. A contaminated drug can cause serious reactions, and a drug with too little of an ingredient may not work.
Feldman said he expects brand-name drugmakers to shift their legal battle to patent infringement when the shortage ends.
He says drugmakers have spent a lot of time and money to bring these drugs to market and will want to validate their scientific claims and regain market share.
Semaglutide compounders are adaptable
Despite seeking comment from more than a dozen Internet phone companies that market semaglutide and tirzepatide, NPR heard only from two.
Hims, a telehealth website, began offering reduced-dose semaglutide in May and said it was exclusively using a generic brand that the FDA said would be banned from making copies once the brand name shortage is over. just. The company did not provide specifics about how its semaglutide business will change after the shortage, but a spokesperson wrote in an email that the company plans to continue providing “personal care.”
Ro, another telehealth website, does not provide details about its plans. “We are committed to providing our patients with the best treatments available and continue to evaluate potential treatment options,” the spokesperson wrote in an email.
The Alliance for Pharmacy Compounding, a trade group for compounding chemicals, says the end of the brand shortage will mean changes for compounding pharmacists.
However, there are ways to continue to prepare different types of semaglutide under federal law “when the representative ruled [a] A certain combination formula is not available commercially and achieves a medical difference to the patient,” says the director of the group, Scott Brunner. “But that will be for providers to identify and prescribe, not pharmacists. “
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