Eli Lilly ramps up its fight against imitation weight-loss drugs

Eli Lilly is ramping up its campaign against imitations of its blockbuster appetite-suppressing drugs, seeking to put an end to a regulatory designation that has allowed cheaper, off-brand versions to flourish.

Lawyers for the drugmaker are notifying health-care providers that shortages of Mounjaro and Zepbound are effectively over, even though the Food and Drug Administration hasn’t yet made that determination. Meanwhile Lilly, whose executives have made verbal jabs at the safety of the pharmacies replicating their drugs, launched a discounted product Tuesday that it billed as a safer alternative to the off-brand medications.

Lilly and rival Novo Nordisk have been battling the emerging industry making copies of their top-selling diabetes and weight-loss drugs, a situation without modern precedent. It started in 2022, when the FDA placed the active ingredients in Lilly’s Mounjaro and Zepbound, and Novo’s Ozempic and Wegovy, on its shortage list, a designation that opened the door for specialized pharmacies to make their own copies.

That has created an unusual opportunity for compounding pharmacies, which typically custom-make medications to suit individual patient needs. They are licensed and inspected by states and the FDA, but the federal agency doesn’t approve such medications and has cautioned that they aren’t as safe as those it exhaustively reviews.

Lilly has made progress boosting its supplies of tirzepatide, the active ingredient in Mounjaro and Zepbound. It has reported that all doses of the drugs are available to the FDA, which publishes the information on its shortage database. Seizing on the public portal showing the drugs as available, Lilly is claiming that its drugs are “commercially available” and that it is no longer permissible for pharmacies to copy them.

Lawyers representing Lilly issued letters, dated Aug. 9, warning prescribers of compounded tirzepatide to immediately cease doing so, according to copies seen by The Washington Post.

But only the FDA can determine when a shortage is resolved. For Mounjaro and Zepbound to meet that threshold, according to agency guidelines, a manufacturer must meet “national historical demand” and demonstrate that it has additional supplies in reserve.

In recent weeks, the FDA has indicated that it is closely evaluating whether the shortage is over.

“The FDA is currently working to determine if the available supply of tirzepatide would meet our definition of a resolved shortage,” an agency spokesperson told The Post on Thursday.

In response to written questions, Lilly acknowledged that Mounjaro and Zepbound remain on the FDA’s shortage list. “In the interest of patient safety, Lilly is working with the FDA to resolve this,” a spokesperson said.

Even as Lilly presses for the agency to end the shortage designation, it has acknowledged the challenges of meeting demand for tirzepatide. The company’s interim chief financial officer said this month that there may be ongoing “variability in the patient experience at the pharmacy counter,” and that rising demand “may result in periodic supply tightness.”

Empower Pharmacy, a compounding pharmacy based in Houston with a national reach, sent a note to clients this month addressing Lilly’s claims that tirzepatide is fully available, according to a copy seen by The Post. “The FDA should be considered the only source of truth on this matter,” the notice said, pointing out that the agency hasn’t removed tirzepatide from its shortage list. Empower encouraged clients to “report to the FDA that you and your patients still face challenges sourcing” the medication.

Shaun Noorian, Empower’s CEO, said in a statement Thursday that it “aims to raise awareness and advocate for a resolution to these supply issues.” He added that compounding pharmacies “have been the primary reason patients have not seen a lapse in their treatment” while the FDA-approved drugs have been in shortage.

Like Lilly, Novo Nordisk also has taken legal action against some compounding pharmacies. The FDA lists one dose of Wegovy as having “limited availability,” and the category of semaglutide remains in shortage. “It’s important that patients are aware that Novo Nordisk is the only company in the U.S. with FDA-approved medicines containing semaglutide,” a Novo spokesperson said.

The runaway success of Mounjaro and Zepbound has taken Lilly to new heights. Lilly’s share price has soared 60 percent so far this year, giving it a stock-market value of about $850 billion, by far the largest of any U.S. company in the health-care and pharmaceutical industries, according to S&P Global Market Intelligence.

But as Lilly and Novo have struggled to meet demand for their weight-loss drugs, many compounding pharmacies have seized the opportunity to make their own versions, functioning like generic producers without having to undergo the FDA’s rigorous review for generics. (There is no approved generic for semaglutide or tirzepatide).

While the drugmakers are spending billions of dollars to build new manufacturing capacity and meet exacting regulatory standards, the pharmacies have much lower overhead costs and can offer their weight-loss products for less than a couple hundred dollars a month.

The availability of compounded weight-loss drugs has given rise to an entire industry of clinics and telehealth firms, taking advantage of the brand-name drugs’ incredible popularity while offering much lower prices.

On Aug. 8, when Lilly announced the latest eye-popping sales, a financial analyst pointedly asked executives what the company planned to do about imitation versions that “take away sales” and could “tarnish the reputation” of its marquee drugs?

CEO David Ricks took the opportunity to deliver a dig at pharmacy-made weight-loss drugs. Lilly is investing heavily in expanding its highly regulated manufacturing plants, which haven’t been able to keep up with demand for its most sought-after drugs, he explained. “So it’s a little odd that the answer to that constraint,” he began, “is to create another industry that is non-sterile product.” He added, “People can get hurt.”

Scott Brunner, CEO of the trade group Alliance for Pharmacy Compounding, said in response that compounded weight-loss drugs that are injectable, like tirzepatide, “can only be prepared in sterile compounding labs.”

A Lilly spokesperson said it has tested compounded tirzepatide that contained “bacteria, high levels of impurities or was just sugar alcohol.” The company declined to say how it has obtained samples to test the prescription-only drug.

In its effort to meet the soaring demand for its weight-loss drug, Lilly announced Tuesday that it will offer Zepbound in a new, cheaper formulation. Instead of using its standard auto-injector pens, the company will sell vials that can be injected with a syringe of its two lowest doses for $399 and $549 a month. The list price is about $1,060 a month.

The company said the vials are a more affordable option for people without insurance or whose insurance won’t cover the weight-loss drug. It also ensures that “patients and providers can trust they are receiving genuine Lilly medicine” while protecting the public from “counterfeit, fake, unsafe or untested knockoffs,” Lilly said.

Because the vials are for people paying cash, the revenue Lilly brings in will be largely similar to what it makes from its standard Zepbound offering after rebates to insurance companies, some Wall Street analysts project. The company also has raised the price of Zepbound in its separate savings program by $100 a month.

Umer Raffat, an analyst at Evercore ISI, said in a note to clients that the net price Lilly gets for Zepbound “may even improve actually.”