Copycat Ozempic Makers Brace For Crackdown

Makers of copycat weight-loss drugs and digital health companies that distribute them are preparing for major changes after the US Food and Drug Administration (FDA) announced that Novo Nordisk's blockbuster drugs, Ozempic and Wegovy, are no longer in shortage.

Why It Matters

The FDA's declaration effectively ends a policy that allowed drug compounders to manufacture lower-cost, off-brand versions of semaglutide injections during the shortage of brand-name medications. This shift could lead to higher costs for patients who rely on these treatments.

Current Scenario

The FDA confirmed that Novo Nordisk now has sufficient quantities of the main ingredient in Ozempic and Wegovy, along with the manufacturing capacity to meet present and anticipated demand. To allow for a transition period, the agency has set a deadline of April 22 for compounders to halt the sale of copycat versions before enforcement begins.

Semaglutide has been in short supply since 2022 due to soaring demand for weight-loss medications in the U.S. Last month, the FDA also announced that tirzepatide, a GLP-1 drug from Eli Lilly, was no longer in shortage. However, the number of people in the U.S. using compounded semaglutide remains unclear.

Industry Concerns

While compounders and pharmacies anticipated an eventual end to the semaglutide shortage, some question whether this decision comes at the right time. Scott Brunner, CEO of the Alliance for Pharmacy Compounding, expressed concern about whether the FDA considered the built-up demand for compounded semaglutide.

"All we can do now is watch how patients react and how their healthcare providers and pharmacists work to secure new prescriptions for FDA-approved medications," Brunner said. He also warned that the higher price of branded semaglutide may make the treatment unaffordable for some patients.

Noom, a digital health company that prescribes compounded semaglutide, argued that access to branded Ozempic and Wegovy remains a challenge for many patients. "Today is not a good day for those suffering from chronic disease, and this decision does not contribute to improving public health," CEO Geoff Cook said in a statement.

Pushback And Adaptation

Despite the FDA’s decision, some digital health companies plan to continue selling compounded semaglutide. Hims & Hers, for example, emphasized its commitment to "personalizing the delivery of existing, clinically studied medications." CEO Andrew Dudum stated that compounders can still produce off-brand drugs when a clinical need exists, such as a different dosage or administration method.

"Precision medicine is about optimizing existing treatments for individuals. We support thoughtful innovation, not shortcuts," Dudum wrote in a post on X. However, the company's stock dropped nearly 26% following the FDA’s announcement.

Novo Nordisk's Response

Novo Nordisk has been engaged in legal battles with compounders over copycat drugs and welcomed the FDA’s ruling. "No one should have to compromise their health due to misinformation and rely on counterfeit or unsafe knockoff drugs," said Dave Moore, executive vice president of U.S. operations and global business development.

The company has committed $6.5 billion this year to expand manufacturing capacity in the US, reinforcing its ability to meet growing demand for its weight-loss drugs.