This week was supposed to signify the end of compounding pharmacies producing copycat versions of Eli Lilly’s weight-loss drug Zepbound and its diabetes drug Mounjaro. However, online platforms such as Amble, EllieMD, Willow, and Mochi Health continue to advertise tirzepatide, the active ingredient in Zepbound. Some entities, like Ivim, have ceased accepting new patients.
Mochi Health CEO Myra Ahmad stated that the company has no intention of stopping its operations and neither do the four pharmacies it collaborates with. Mochi employs a network of approximately 500 providers to prescribe weight-loss drugs, including compounded versions. The company believes that offering personalized drug formulations will help them avoid regulatory scrutiny.
“It can be different dosing schedules… some patients prefer to go up in dosage much more slowly,” Ahmad explained. “Some patients like to mix a number of other medications into their compounded formulations, depending on the side effects that they’re having. Some patients have side effects with any additives and brand name formulations. Compounding really opens up the door for so much personalization.”
Amble, EllieMD, and Willow did not respond to requests for comment from CNBC.
Compounding involves pharmacies mixing drug ingredients to create specialized versions for specific patients. For instance, if someone is allergic to a dye in a branded medication or requires a liquid form when only capsules are available, they can opt for a compounded version. When drugs are in short supply, they can be compounded in larger quantities to bridge the gap.
Copycat versions of Lilly’s Mounjaro and Zepbound and Novo Nordisk’s Wegovy and Ozempic have been widely available in recent years due to the U.S. Food and Drug Administration listing the branded versions as being in short supply. This created a booming business for pharmacies compounding the popular class of weight loss and diabetes medications called GLP-1s.
However, late last year, the FDA declared all doses of Mounjaro and Zepbound readily available and removed the drugs from its shortage list, signaling the end for mass compounding. After months of legal challenges, the FDA gave smaller pharmacies until early March and larger ones until this week to comply before enforcement began.
Larger facilities are no longer permitted to compound tirzepatide at all. Smaller ones are not supposed to produce products that are essentially copies of commercially available drugs. The FDA defines essential copies as those with a dosage within 10% of the commercially available drug or combining two or more commercially available drugs.
Mochi insists all its prescriptions are personalized, including doses that differ from standard Zepbound strengths. Other websites like EllieMD advertise tirzepatide mixed with vitamin B12.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, stated that formulations or dosage strengths not commercially available aren’t considered copies. However, combining two drugs into one would be considered a copy under a strict reading of FDA guidance.
“FDA guidance is pretty clear about what is and is not a copy,” Brunner said. “And I would say any compounding pharmacy or outsourcing facility that continues to prepare copies of tirzepatide injection after today are putting themselves in a certain amount of legal risks.”
John Herr, pharmacist and owner of Town & Country Compounding Pharmacy, stopped compounding tirzepatide earlier this month. He didn’t want to take the risk even though his 300 to 400 patients on it have been calling nonstop to complain about losing access.
Town & Country, based in Ramsey, New Jersey, was charging patients about $200 a month — about one-fifth the list price for Zepbound and less than half the price Lilly charges self-paying patients.
What happens next remains uncertain. Enforcing the ban on mass compounding of tirzepatide primarily falls to the FDA. The agency did not immediately respond to CNBC’s request for comment.
Lilly could attempt to sue companies that continue, but it hasn’t had much success in the past. A Florida judge last year dismissed one of Lilly’s cases, stating the company was trying to enforce a law only the FDA can.
Ahmad, the CEO of Mochi, said she isn’t worried about Lilly taking legal action against her providers. She believes they have established patient-physician relationships with the autonomy to decide how best to manage their patients.
The next two months will be informative. Mass compounding of semaglutide — the active ingredient in Novo Nordisk’s Ozempic and Wegovy — needs to stop by the end of May, according to the FDA.
Hims & Hers Health has already announced it will stop selling commercially available doses of semaglutide when the time comes. Customers with personalized dosing regimens will be able to continue without any change.
— news from CNBC