Novo Nordisk (NVO) won a key case Thursday to stop some complex pharmacies from selling counterfeit versions of its blockbuster GLP-1 drug. But that won't end all composite products.
The Texas federal court ruling opened the door to action for the U.S. Food and Drug Administration, which could have stopped selling Comply Semaglutide – the active ingredient in diabetes drugs Ozempic and Wighter-toge-toge-togers wegovy wegovy – next month, the company said in a statement Friday.
That was the deadline for the FDA to announce the end of last year's drug shortage. The judge denied the FDA's efforts to completely eliminate the shortage by freezing the compound.
The Compound Industry Trade Group Outsourcing Facilities Association said in a statement Friday that the ruling disappointed the ruling but intends to continue through legal processes and discussions with the FDA.
Compound and telemedicine providers continue to serve Novo's Semaglutide and Eli Lilly's Tirzepatide, a key ingredient in the diabetes drug Mounjaro and the weight loss drug zepbound.
However, Lily recently sued the telemedicine platform that sells its composite products.
Telemedicine and other online platforms such as Lemonad, Ro and Hims & Her (HIMS) offer sophisticated Semaglutide, which, despite Texas rulings, can legally allow for continued doing so.
This is because according to the FDA regulations that govern their operations, there are two different types of composite pharmacies, 503a and 503b. According to industry experts, the latter was affected by the ruling.
However, 503AS can exploit vulnerabilities: they can still make semaglutide copies that are not “essential copies” of drugs. This means they can make a Semaglutide version that is different or nearly identical to Ozempic and Wegovy.
Although the FDA allows this, it also warns on its website: “While complex drugs can meet important needs, they can also pose higher risks to patients than FDA-approved drugs.”
HIMS has a 503A pharmacy to aggravate GLP-1, so if the formula is not a necessary copy, you can continue to provide them.
ROs also use 503A pharmacies, but it is not clear whether they produce the Semaglutide provided by RO.
“We will continue to work to ensure that our patients can meet their individual needs and goals the best treatment approach and follow applicable FDA rules and compound regulations,” Rowe said in a statement Friday.
