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GLP-1 weight-loss drugs are now the focus of a heated legal battle, with a leading drugmaker warning that copycat versions pose a risk to patient safety.
“When you go and try to source raw materials from China or unknown sources, put it in an injection, and sell knockoff medication, there is something wrong with this,” Mike Doustdar, president and CEO of Novo Nordisk, told FOX Business’ Maria Bartiromo.
Novo, best known for its blockbuster diabetes drug Ozempic and weight-loss treatment Wegovy, has filed a lawsuit against Hims & Hers Health, accusing the telehealth company of selling compounded, unapproved versions of its semaglutide-based medications, including a copycat version of its newly launched daily pill.
Doustdar said the introduction of the oral option broadens access for patients who are reluctant to use injections, but he sharply criticized what he described as widespread “mass compounding” of GLP-1 drugs by telehealth firms.
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“Compounding is supposed to be for a few individuals that have, let’s say, allergic reactions to the real medicine,” he said. “But this mass compounding — it’s quite unbelievable that it has gotten to this point.”
He added that Novo has filed multiple lawsuits against compounders, arguing that the launch of a compounded pill version crossed a line.
“I think the nail in the coffin, as they say, was when they completely made a new drug — the pill — a compounded version of it and basically tried to introduce that to the market,” he said. “That’s where we felt enough is enough.”
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Hims & Hers fired back against Novo Nordisk in a statement issued to multiple outlets this week, blasting the legal move as “a blatant attack by a Danish company on millions of Americans who rely on compounded medications for access to personalized care” and accusing “Big Pharma” of “weaponizing the U.S. judicial system to limit consumer choice.”
“This lawsuit attacks more than just one medication or company – it directly assaults a well-established, vital component of U.S. pharmacy practice that has improved patient care for everything from obesity to infertility to cancer,” a representative for the company said, per the New Jersey business publication NJBIZ.
The company also cited its history of providing “safe access to personalized healthcare to millions of Americans,” adding that it will “continue to fight to provide choice, affordability and access.”
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For some time, patients seeking GLP-1 therapy for conditions such as obesity, type 2 diabetes, fatty liver disease and metabolic syndrome have sought compounded alternatives after facing insurance roadblocks that created cost challenges for brand-name medications.
Doustdar said Novo’s recent cost reductions have eliminated the need for copycat drugs due to what he described as pricing similarities between branded and compounded versions.
However, when Hims & Hers briefly launched its compounded oral semaglutide, it was marketed at about $49 per month as an introductory price and around $99 per month thereafter, lower than Novo’s FDA-approved oral Wegovy, which launched at roughly $149 per month and can cost up to $299 at higher doses under self-pay pricing.
Hims & Hers later pulled the oral compounded medication from its platform following legal threats from Novo and scrutiny from federal regulators.
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