Novo Nordisk is ramping up its war on compounders making versions of its top-selling semaglutide medicine as the regulatory grace period for their products officially ends.
The Danish drugmaker on Thursday said it’s launching a “Choose the Real Thing” campaign designed to alert consumers of the potential dangers of knockoff products. It’s also offering self-paying customers a $300 discount for their first prescription of name-brand Wegovy and intensifying legal actions that have already spawned almost 120 lawsuits.
“Mass compounding of `semaglutide’ is illegal, dangerous and must stop now,” Dave Moore, Novo’s executive vice president of U.S. operations, said in the company’s statement.
Novo’s profits soared over the last few years as consumers raced to take drugs made with semaglutide – including Ozempic for diabetes and Wegovy for obesity – along with similar medicines made by Eli Lilly. Both Novo and Lilly struggled to keep up with demand, and compounders and telehealth companies like Hims & Hers stepped in, offering cheaper compounded versions of the GLP-1 medications.
The Food and Drug Administration allowed the compounded products while shortages persisted. But now that Novo and Lilly have caught up with demand, the FDA said that large-scale compounding must stop. The agency allowed compounding pharmacies to phase out their work, and the last grace period ended Thursday.
But Novo clearly sees a continued risk of compounding, which has hurt earnings growth and added to woes including supply chain issues, clinical trial setbacks and increased competition from Lilly. Novo this month announced its longtime CEO, Lars Fruergaard Jørgensen, would step down.
An attempt by compounders to reverse the FDA decision in court failed last month, but companies are still seeking ways around the ruling. At least one, Noom, plans to keep offering versions of semaglutide, saying its tailored method of titrating dosages complies with the law allowing compounding to fit personalized patient needs, Axios reported.
Novo contends that almost all of the compounded semaglutide is manufactured in China and by other foreign suppliers and may be dangerous for patients. The company notes that the FDA hasn’t subjected compounders to the same rigorous production standards that Novo and Lilly must meet.
The one-time Wegovy discount offer is good through June 30. It allows patients with a prescription for semaglutide who are new to brand-name Wegovy to pay $199 for their first month of medicine. After that, the cost will climb to $499 a month.
