The drugmaker warns that GLP-1 mimic drugs pose serious safety risks to patients


GLP-1 weight loss drugs are now the focus of a heated legal battle, with a major drug maker warning that copied versions poses a risk to patient safety.

“When you go and try to get raw materials from China or from unknown sources, put them in an injection and sell knock-out drugs, there’s something wrong,” Mike Doustdar, president and CEO of Novo Nordisk, told Maria Bartiromo of FOX Business.

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 drugs, including a copycat version of its recently launched daily pill.

Doustdar said the introduction of the oral option expands access for patients who are reluctant to use injections, but he strongly criticized what he described as widespread “mass compounding” of GLP-1 drugs by telehealth companies.

DANGEROUS ‘GRAY MARKET’ WEIGHT LOSS DRUGS FLOODING US AS EXPERTS WARN OF RISKS

Woman taking a GLP-1 injection

A woman gets an injection of GLP-1 in her stomach in this undated photo taken at an undisclosed location. (iStock)

“The compound is supposed to be for a few people who have, shall we say, allergic reactions to the actual medicine,” he said. “But this massive combination is pretty incredible that it’s gotten to this point.”

He added that Novo has filed several lawsuits against the compounds, arguing that releasing a compound pill version crossed a line.

“I think the nail in the coffin, as they say, was when they made a completely new drug, the pill, a compound version and basically tried to bring that to market,” he said. “That’s where we felt enough is enough.”

PROTEIN GOALS, SUPPLEMENT OFFERS, CAPITALIZING ON THE WEIGHT LOSS TREND

Pharmacist with a box of Wegovy 1.5 mg tablets

A pharmacist displays a box of Wegovy pills at a pharmacy in Provo, Utah, on Thursday, Jan. 15. (George Frey/Bloomberg via Getty Images)

Hims & Hers took a shot at Novo Nordisk in a statement published in various outlets this week, calling the legal action “a blatant attack by a Danish company on millions of Americans who rely on compounded drugs to access personalized care” and accusing “Big Pharma” of “weaponizing the American judicial system to limit consumer choice.”

“This lawsuit attacks more than a drug or a company; it directly attacks a vital, well-established component of American pharmaceutical practice that has improved patient care for everything from obesity to infertility to cancer,” a company representative said, according to New Jersey business publication NJBIZ.

The company also cited its history of providing “secure access to personalized health care to millions of Americans,” adding that it will “continue to fight to provide choice, affordability and access.”

AIRLINES HAVE 580 MILLION REASONS TO PICK UP GLP-1 FOR WEIGHT LOSS, ANALYSIS FINDS

The New York Stock Exchange with a Hims and Hers banner

The New York Stock Exchange with a Hims & Hers Health, Inc. banner. is pictured as a person runs past in the Manhattan borough of New York City, New York on January 21, 2021. (Carlo Allegri / Reuters)

For some time, patients seeking GLP-1 therapy for conditions such as obesity, type 2 diabetes, fatty liver disease and metabolic syndrome have sought combination alternatives after facing insurance roadblocks that created cost challenges for brand-name drugs.

Doustdar said Novo’s recent cost reductions have eliminated the need for copycat drugs because of what he described as price similarities between branded and compounded versions.

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However, when Hims & Hers briefly launched its oral compound semaglutide, it was marketed at about $49 per month as an introductory price and around $99 per month thereafter, lower than Novo. FDA approved oral Wegovy, which launched at about $149 per month and can cost up to $299 at higher doses with self-pay pricing.

Hims & Hers later pulled the oral compound medication from its platform following legal threats from Novo and scrutiny from federal regulators.



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