As concerns around knockoffs of newer GLP-1 drugs like Ozempic and Wegovy take center stage, Novo Nordisk’s efforts to ward off competition against its aging diabetes blockbuster Victoza have been quietly simmering in the background.
In a citizen petition posted by the FDA this week, Novo urged the regulator to restrict the ability of compounding pharmacies to produce Victoza, also known as liraglutide, following a proposal by the trade group the Outsourcing Facilities Association (OFA) to add the molecule to its compounding roster.
Apart from Victoza, which was approved for Type 2 diabetes in 2010, liraglutide also underpins Novo’s older weight loss drug Saxenda and its insulin-degludec-based diabetes combination therapy Xultophy.
While a newer class of GLP-1s based on Novo’s semaglutide has redefined the Danish drugmaker’s business in recent years, Victoza remained one of the company’s top earning drugs in 2023, when it brought home (PDF) sales of nearly 8.67 billion Danish kroner (around $1.2 billion).
Meanwhile, generic drug makers have already sought out to capitalize on liraglutide’s success. Teva launched an authorized generic for Victoza in the U.S. in June, while Hikma has already rolled out its own copycat following an FDA approval that came through shortly after Christmas.
Complicating the issue for Novo, generic drug makers and compounders, however, is the fact that certain doses of Victoza and Saxenda are currently listed on the FDA’s online drug shortage database, presenting a potential opportunity for outsourcers to make their own versions of the drug.
To hear Novo tell it, the outsourcing group OFA shouldn’t be allowed to place liraglutide on its compounding list given that FDA-approved generics to Victoza are available. Further, the OFA has failed to “establish a clinical need” to compound drugs using liraglutide, Novo’s lawyers argued in the petition.
Novo additionally argued that producing liraglutide is tricky and that “even small changes in the manufacturing process … can substantially affect its chemical and physical stability, as well as its impurity profile.”
Novo has made similar claims about the challenges of Victoza manufacturing in the past.
Back in 2017, the drugmaker filed a separate citizen petition arguing that the production process for the GLP-1 was so complex that any generic hopefuls should need to prove their equivalence via clinical trials.
More recently, Novo has largely shifted its attention toward knockoff versions of its newer GLP-1 meds, Ozempic for Type 2 diabetes and Wegovy for obesity, both of which are girded by the molecule semaglutide.
In October, Novo asked the FDA to prevent compounders from producing copycats of Ozempic and Wegovy, again making the argument that the treatments are too complex to replicate safely.
Novo specifically requested semaglutide be added to the FDA’s Demonstrable Difficulties for Compounding lists, citing complexities around formulations, delivery mechanisms, dosage forms, bioavailability and more.
Meanwhile, Novo’s chief rival in the metabolic medicine space, Eli Lilly, adopted a similar tack this week when it filed a motion to intervene in a lawsuit brought by the OFA—the same compounding organization at the center of Novo’s petition—attempting to sway the FDA to reverse its decision to declare the shortage of Lilly’s dual GIP/GLP-1 agonist tirzepatide resolved.
Lilly posed similar arguments to Novo’s, contending in a legal filing this week that compounded versions of tirzepatide—which is marketed under the brand names Mounjaro and Zepbound—aren’t beholden to the same safety and quality standards as the Lilly products they reference.
Beyond this week’s legal filings, both Novo and Lilly have been waging a broader legal campaign against health spas, clinics and pharmacies in a bid to corral imitations of their highly-profitable incretin drugs.
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