Copycat Ozempic makers brace for crackdown
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Makers of copycat weight-loss drugs and digital health companies that sell them are bracing for upheaval now that the Food and Drug Administration has declared Novo Nordisk's blockbusters Ozempic and Wegovy are no longer in shortage.
Why it matters: The announcement on Friday effectively ends an FDA policy that allowed drug compounders to make less expensive off-brand versions of the semaglutide injections when the brand-name products are in short supply. And it may force patients to pay more to stay on their regimens.
State of play: The FDA said it confirmed with Novo Nordisk that it has enough of the main ingredient in Ozempic and Wegovy and the manufacturing capacity to meet current and projected demand.
- To provide a wind-down period, compounders have until at least April 22 to stop selling copycat versions before the agency starts enforcing the cutoff.
- Semaglutide has been in shortage since 2022 as demand for weight-loss drugs has surged in the U.S. The FDA just last month declared that tirzepatide, another GLP-1 drug manufactured by Eli Lilly, was no longer in shortage.
- There's no clear data on how many people in the U.S. take compounded semaglutide.
Where it stands: Compounders and pharmacies knew the semaglutide shortage would end at some point but are questioning whether now is the appropriate time to declare it over.
- Alliance for Pharmacy Compounding CEO Scott Brunner asked whether the FDA took into account the demand that's built up for compounded semaglutide specifically.
- "All we can do now is watch what happens as patients hear this news and their providers and pharmacists work to get them a new prescription for the FDA-approved drug," he said in a statement, adding that the sticker shock of branded semaglutide may put the therapy out of reach for some patients.
- Noom, a digital health company that prescribes compound semaglutide, said it believes patients are still having trouble accessing the branded Ozempic and Wegovy.
- "Today is not a good day for those suffering from chronic disease, and today's action is not contributing to making America healthy again," CEO Geoff Cook said in a statement.
Yes, but: Digital health company Hims & Hers said it will continue selling compounded semaglutide as it seeks to "personalize the delivery of existing, clinically studied medications," CEO Andrew Dudum wrote in a post on X Friday.
- Compounders can still make off-brand versions of drugs when there's a clinical need, such as when a patient needs a different dosage or way to administer the medicine.
- "Precision medicine is about making existing treatments work better for individuals. We're proud to stand for thoughtful innovation, not shortcuts," Dudum wrote.
- The company's stock nonetheless fell nearly 26% on Friday following the FDA's announcement.
The other side: Novo Nordisk, which has sparred with compounders over the copycat drugs, applauded the FDA decision.
- "No one should have to compromise their health due to misinformation and reach for fake or illegitimate knockoff drugs that pose significant safety risks to patients," Dave Moore, executive vice president of U.S. operations and global business development, said in a statement.
- The company confirmed it's committed $6.5 billion dollars for increasing manufacturing capacity in the U.S. since the start of this year.
Go deeper: Insurers push back on Medicare and Medicaid coverage for GLP-1s
