By Liz Essley Whyte

Today was supposed to mark the beginning of the end for cheaper, knockoff versions of hot weight-loss drugs. The Food and Drug Administration wants bulk production of the copycats to stop -- starting Wednesday for pharmacy-prepared versions of Zepbound and later in the spring for knockoffs of Ozempic and Wegovy.

But telehealth companies and pharmacies that have fueled wide use of copycats have other plans.

Telehealth platform Hims & Hers Health says it will keep offering pharmacy-made, or compounded, versions of Ozempic and Wegovy tweaked to individual prescriptions. And some of the pharmacies making the GLP-1 drug copycats will continue, according to people familiar with the industry.

The firms are seeking to take advantage of current law, which allows compounding pharmacies to make special, individualized versions of drugs that aren't available commercially. Telehealth firms and pharmacies instead intend to sell versions of the obesity drugs tailored for specific patients whose doctors say they need a different dosage than one of the original drugs or a version with extra vitamins added.

"A lot of these patients won't be able to afford switching over to a brand-name medication," said Dr. Taylor Kantor, a co-founder of Ivim Health, a telehealth platform offering obesity drugs. "We're trying to make sure those patients aren't left in the dust."

The FDA deadlines come after the agency declared the official end of the obesity-drug shortages that allowed compounding pharmacies to make copies of the drugs in bulk. The shortages' end has led to a fierce fight in the courts, on the airwaves and around Washington with the pharmaceutical heavyweights Eli Lilly and Novo Nordisk that sell the branded drugs.

Eli Lilly Chief Executive David Ricks said compounders want to profit off the drugs without the stringent safety regulations and hefty upfront research costs that brand-name pharmaceutical firms face. "These outfits want all the benefits of being drug companies without any of the responsibilities," Ricks said in an interview.

Demand for the weight-loss drugs increased so much, so quickly that Eli Lilly and Novo Nordisk couldn't keep up. Due to the shortages, pharmacies that make custom-made, or compounded, versions were allowed to help fill the gap.

Advocates for compounding pharmacies now estimate they have supplied roughly 10 million patients with compounded weight-loss drugs in the past year.

Telehealth companies often sold the compounded drugs at $100 to $300 a month, well below the $1,000-plus price tags of the branded medicines. (Lilly and Novo Nordisk now sell certain doses directly to customers paying cash for roughly $500 a month.)

Since ramping up production, Eli Lilly, which makes Mounjaro and Zepbound, and Novo Nordisk, manufacturer of Ozempic and Wegovy, have been sending cease-and-desist letters and filing lawsuits to contain their compounding competitors.

Compounders can't evade federal law under "the guise of making 'personalized' drugs," said a Novo Nordisk spokeswoman. She said the company has filed 105 lawsuits in federal courts alleging the unlawful marketing and selling of fake or illegitimate knockoffs.

Compounders, who say their medicines are safe, have fought back in the courts, filing lawsuits challenging the FDA's decisions to declare the drug shortages over.

The battle has also hit the airwaves. Hims & Hers touted its weight-loss offerings with a Super Bowl ad, while Lilly urged a "healthy skepticism" toward compounded medications in an ad that ran during the Oscars. Meantime, Novo Nordisk has an advertising campaign against compounded drugs that urges patients to "check before you inject."

Hims & Hers referred to a March 2 social-media post by Chief Executive Andrew Dudum saying the firm would stop selling commercially available doses in mid-May, but would keep providing compounded versions if they have been getting a personalized dosing regimen.

Dudum also encouraged customers to work with Hims & Hers to explore "alternative options that could meet your needs."

Lobbying in Washington has intensified. Novo Nordisk hired a Trump-aligned firm, Checkmate Government Relations, and former White House health aide Greg D'Angelo, according to federal records. Hims & Hers, likewise, hired two new lobbying firms in January.

Ivim recently hired one of its patients, former Trump press secretary Sean Spicer, to help it raise awareness about the deadlines.

Brigham Buhler, an influencer in the Make America Healthy Again movement who is the co-founder of compounding pharmacy ReviveRX, said he and others have sent a letter to Dr. Marty Makary, President Trump's nominee to lead the FDA, underlining the importance of compounded drugs.

Buhler and others argue that limiting compounded versions of the drugs will boost unsafe, gray-market websites offering the active ingredients nominally for research use but really targeting sales to patients.

Scott Brunner, chief executive of the trade group Alliance for Pharmacy Compounding, says compounders provide vital services to American hospitals and patients, but they have to be careful about competing directly with pharmaceutical companies.

"Picking a fight with drugmakers may put compounded therapies at risk," he said.

Write to Liz Essley Whyte at liz.whyte@wsj.com

(END) Dow Jones Newswires

March 19, 2025 11:54 ET (15:54 GMT)

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