Novo Nordisk (NVO) won a key case Thursday to stop some compounding pharmacies from selling knockoff versions of its blockbuster GLP-1 drugs. But it won’t end all compounding offerings.
The company said in a statement Friday that the ruling in Texas federal court opens the door for the US Food and Drug Administration to take action against compounding pharmacies, which are supposed to halt selling compounded semaglutide — the active ingredient in diabetes drug Ozempic and weight-loss drug Wegovy — next month.
That was the deadline set by the FDA when it declared an end to a shortage of the drugs last year. The judge denied the compounders’ efforts to freeze the FDA’s decision to end the shortage altogether.
The Outsourcing Facilities Association, a compounding industry trade group, said in a statement Friday it was disappointed by the ruling but intends to keep fighting through the legal process and in discussions with the FDA.
Compounders and telehealth providers have continued their offerings for both Novo’s semaglutide and Eli Lilly’s (LLY) tirzepatide — the key ingredient in diabetes drug Mounjaro and weight-loss drug Zepbound.
But Lilly recently sued telehealth platforms that were selling its compounded products.
Telehealth and other online platforms like Lemonaid, Ro, and Hims & Hers (HIMS) offer compounded semaglutide — and could be legally allowed to continue to do so despite the Texas ruling.
That’s because there are two different types of compounding pharmacies, 503A and 503B, based on the FDA regulations that govern their operations. The latter is impacted by the ruling, according to industry experts.
The 503As, however, could exploit a loophole: They can still make semaglutide copies that are not “essential copies” of the drug. That means they can make a version of semaglutide that is not identical or nearly identical to Ozempic and Wegovy.
While the FDA allows this, it also warns on its website, “Although compounded drugs can serve an important need, they can also pose a higher risk to patients than FDA-approved drugs.”
Hims owns 503A pharmacies for compounding the GLP-1s, so it could continue to offer them if the formulas are not essential copies.
Ro also uses 503A pharmacies, but it is unclear if they produce the semaglutide that Ro offers.
In a statement Friday, Ro said, “We will continue to work to ensure that our patients can access the best treatments for their individual needs and goals, and follow applicable FDA rules and regulations on compounding.”
