GLP-1 drugs no longer in shortage

In October, FDA announced that Eli Lilly's GLP-1 drug tirezepatide was no longer in shortage after the company determined that its manufacturing capacity could meet "present and projected" demand for the drug. Tirezepatide is also known by its brand names Zepbound and Mounjaro.

Although FDA initially reevaluated its decision to remove tirzepatide from its shortages list following a lawsuit from the Outsourcing Facilities Association, the agency later reaffirmed that the GLP-1 drug was no longer in shortage.

Last week, FDA announced that there was no longer a shortage of Novo Nordisk's GLP-1 semaglutide, which is also branded as Ozempic and Wegovy.

"We are pleased the FDA has declared that supply of the only real, FDA-approved semaglutide medicines is resolved, affirming that Novo Nordisk is meeting or exceeding current and projected nationwide demand," said Dave Moore, the company's EVP of U.S. operations and global business development.

However, FDA noted that "patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies."

How will companies offering compounded GLP-1 drugs be impacted?

Currently, U.S. regulations allow companies to offer compounded versions of drugs only when the brand-name versions are in short supply. Since GLP-1 drugs have been in shortage since 2022, several companies such as Hims & Hers, Ro, and WeightWatchers have offered compounded versions of the drugs. 

"You've got essentially millions of patients that are on these medications. We're still seeing evidence of a shortage and evidence of supply issues," said Taylor Kantor, co-founder and CMO of telehealth company Ivim Health. "You're going to have all those patients that are basically adding to a marketplace if their access point is removed in compounded medications, which could potentially impact the availability of the branded medications."

Kantor also noted that there are affordability issues with branded GLP-1 drugs, which can cost over $1,000 a month compared to less than $200 a month for compounded versions. These high prices could lead some patients to buy counterfeit medications online, he said.

"With the socioeconomic constraints, the cost variables that are at play, we have huge concerns that a large percentage of our patient base that is reliant on compounded formularies that you can get for $100 to $200 a month and now they are faced with having to pay $1,000, we're concerned about where those patients are going to go," Kantor said. 

Currently, some companies, including Hims & Hers, have indicated that they will pivot to other weight-loss drug options, including oral-based medications and another GLP-1 drug called liraglutide. Hims CEO and cofounder Andrew Dudum also noted that the company will comply with regulations on compounded semaglutide and move away from offering them, unless the drugs are clinically necessary for a patient.

"I would suspect we will have to start notifying customers in the coming month or two that they will need to start looking for alternative options on [compounded GLP-1s]," Dudum said. "Obviously, we have the expansive platform, whether it be oral medications that are already out there, or the patient [might] qualify for some level of personalization that exists." 

For their part, both Eli Lilly and Novo Nordisk have taken aggressive action against companies selling "copycat" versions of drugs, arguing that these drugs are not held to the same safety standards as branded drugs. Both companies have filed several lawsuits related to copycat versions of their drugs and asked FDA to prohibit compounding of their drugs.

 "No one should have to compromise their health due to misinformation and reach for fake or illegitimate knockoff drugs that pose significant safety risks to patients," Moore said.

In addition, Eli Lilly on Tuesday announced plans to offer more doses of its GLP-1 drug and lower the prices of already available doses to help patients access the branded medication more easily. Under the new pricing, 2.5-mg vials will cost $349 per month and 5-mg vials will cost $499 per month.

"Every major medical organization and establishment recognizes obesity as a chronic disease, yet insurance and federal programs do not systematically cover people living with obesity for medical care — this needs to change," said Patrik Jonsson, EVP and president of Lilly Cardiometabolic Health and Lilly USA. "Lilly is committed to working with all parties to solve this problem, and in the meantime, we'll continue to implement new options that improve the affordability and availability of our safe, approved and studied Zepbound for patients who are being asked to pay out-of-pocket."