Compounders cast adrift after semaglutide shortage ends
Hims & Hers' new peptide facility.
The FDA has said there is no longer a shortage in the US market for Novo Nordisk's GLP-1 agonist semaglutide, blocking sales of copycat forms of the drug that have made a lot of money for compounding pharmacies.
The drug – sold as Ozempic for diabetes and Wegovy as a weight-loss therapy in the US – has been in short supply since 2022 thanks to skyrocketing demand. Under US law, a brandname drug on the FDA shortage list can be made available by compounding pharmacies, even if still under patent protection.
Last year, Novo Nordisk petitioned the FDA to try to block compounded versions of its drug, arguing that it is too complex to be made safely by these manufacturers, but so far has been unsuccessful. Compounding of another big-selling GLP-1 drug – Eli Lilly's tirzepatide – was blocked in December after that also came off the shortage list.
The end of the official shortage status for semaglutide came as telehealth company Hims & Hers – which has been pushing sales of compounded semaglutide hard and lambasting the pharma industry for restricting access to GLP-1 drugs – bought a peptide facility to raise its manufacturing capacity, sparking a sharp drop in its share price.
In a post on X, Hims & Hers' chief executive, Andrew Dudum, said that the company will "continue to offer access to personalised treatments as allowed by law to meet patient needs," and will be "closely monitoring" the semaglutide supply chain, given that Novo Nordisk "stated two weeks ago that it would continue to have 'capacity limitations' and 'expected continued periodic supply constraints and related drug shortage notifications'."
For its part, the FDA said it "has determined the shortage of semaglutide injection products, a glucagon-like peptide 1 (GLP-1) medication, is resolved." The agency will continue to allow compounders to provide semaglutide to patients on a temporary basis "to avoid unnecessary disruption to patient treatment."
State-licensed pharmacy or physician compounders can continue to do so until 22nd April, while outsourcing facilities have a deadline of 22nd May.
At present, the only GLP-1 products on the shortage list are dulaglutide, sold by Eli Lilly under the Trulicity brand, and liraglutide which Novo Nordisk sells as Victoza. Both are FDA-approved to treat type 2 diabetes.
The Alliance for Pharmacy Compounding, which says that millions of doses of semaglutide and tirzepatide have been prepared and dispensed by compounding pharmacies across the US over the last two years, questioned whether the FDA had considered the number of patients who would need to transition from compounded semaglutide to the FDA-approved brands before changing its status.
