The situation: The compounded GLP-1 market isn’t dying down as quickly as previously expected.
Catch up quick: Companies were permitted to make compounded versions of Novo Nordisk’s semaglutide and Eli Lilly’s tirzepatide when the brand-name versions were in short supply.
Blockbuster GLP-1s are no longer on the FDA’s shortage list, and pharmacies and other facilities must stop mass compounding semaglutide and tirzepatide. But this FDA rule only applies to identical or nearly identical versions of a commercially available drug. The FDA allows “personalized GLP-1s” that have modified formulations or customized doses to be prescribed at the clinician’s discretion.
3 recent developments validating the active compounded GLP-1 market:
1. Sales of Novo’s brand-name Wegovy are coming in lower than forecasted, while many patients are being prescribed compounded semaglutide.
Novo was expecting about 1 million patients who were taking compounded semaglutide to transition to the branded product. But that hasn’t happened, and the company’s CEO said on its Q2 earnings call that the copycat GLP-1 market is “of equal size” to Novo’s business—-likely due to the lower cost of compounded drugs.
2. Online weight loss drug players have not shied away from marketing new compounded GLP-1 offerings.
Noom, for instance, is now selling microdoses of compounded GLP-1 semaglutide for weight loss with a lower price tag and fewer side effects. Noom’s CEO, Geoff Cook, told EMARKETER that Big Pharma is trying to exert its influence to shut down competition—but he’s not expecting that to happen since Noom is adhering to FDA guidance.
Mochi Health is one of the 14 companies recently sued by Novo, and is also dealing with a lawsuit from Eli Lilly. Mochi’s CEO, Dr. Myra Ahmad, told EMARKETER that drug personalization is needed for patients who may require a lower dose or a different formulation due to experiencing side effects. “We’ll continue to allow providers to prescribe the way they see fit,” said Ahmad.
Hims & Hers, meanwhile, is now marketing $199 per month compounded semaglutide for customers who pay 12 months in full.
3. The feds are focusing their efforts on companies selling counterfeit weight loss drugs rather than shutting down the compounded GLP-1 drug market.
Updated July guidance from the FDA includes resources for patients to flag illegal online pharmacies and unsafe products. For context: Compounded medications aren’t FDA approved, but the agency does regulate pharmacies that make copycat drugs.