Novo Nordisk Pvt. Ltd. announced that it has filed a lawsuit against telehealth company Hims & Hers Inc. for mass marketing cheaper, compounded, and unapproved dupes of its original weightloss drugs Ozempic and Wegovy.
According to the company, Hims launched and abruptly discontinued its "compounded" GLP-1 Pill right after Novo Nordisk introduced the Wegovy pill, the first and only FDA-approved GLP-1 drug for weight loss.
Novo Nordisk has asked the court to permanently prohibit Hims from selling unapproved, compounded drugs that infringe on its patents. Further, it has also sought recovery of damages from the company.
The Food and Drug Administration had earlier notified that it will be taking action against compounded GLP-1 drugs mass-marketed by Hims and other compounding pharmacies.
"In promotional materials, companies cannot claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA. They also cannot state compounded drugs use the same active ingredient as the FDA-approved drugs or that compounded drugs are clinically proven to produce results for the patient," the FDA stated.
After receiving scrutiny from federal regulators and legal threats from the Danish drugmaker, Hims agreed to stop the sale of its copycat drugs and injections.
Initially, Hims had planned to sell the drug at a sharply discounted price of $49 for the first month, which is almost $100 less than Novo's approved Wegovy pill.
Besides this, Novo's lawsuit escalates the conflict it has with Hims, and comes at a time when the drugmakers attempt to reclaim ground in a booming obesity drug market, and compete with big players like Eli Lilly.
One of the key ingredients in Novo's blockbuster drugs, Semaglutide, is available in abundance in the United States after the company's efforts to expand its manufacturing, according to reports.
Novo claimed that the US-patented and protected ingredient was unlawfully found in Hims' drugs as well, to which the telehealth company countered that its dosage was "personalised".
But Novo added that it does not directly or indirectly sell semaglutide for copycats, and alleged that Hims is engaging in illegal mass compounding.
"Compounded semaglutide products may contain dangerous impurities or incorrect amounts of active ingredients, which can result in life-threatening immune responses, hospitalisation, severe drug-drug interactions, and overdoses. According to Novo Nordisk's testing, injectable semaglutide drugs compounded by pharmacies were found to contain impurities of up to 86%, with compounded oral semaglutide drugs containing impurities as high as 75%," Novo stated in its release.
It highlighted that even small quantities of such impurities can negatively impact the safety and efficacy of a drug product, including unwanted immune responses like anaphylactic shock.
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