Semaglutide compounder drops claims after Novo Nordisk challenge

A Novo Nordisk challenge has driven a Pennsylvania-based telehealth company to voluntarily discontinue compounded semaglutide product claims, adding to the Danish drugmaker’s string of wins against companies selling copycat versions of its GLP-1 blockbuster.

Novo challenged claims made by Regen Doctors via BBB National Programs’ National Advertising Division (NAD). The challenge centered on express and implied claims about the superiority, safety, efficacy and health benefits of Regen’s compounded semaglutide product. Novo sells the GLP-1 receptor agonist semaglutide under the brand names Ozempic and Wegovy.

After the NAD began looking into the challenge, Regen told the self-regulatory body that it had permanently discontinued the claims, according to an NAD report Thursday. Regen’s actions prompted the NAD to stop reviewing the claims, and the watchdog said it will treat the discontinued claims as if it recommended that Regen stopped making the statements.

The case is part of a series of challenges Novo has recently brought against semaglutide compounders via the NAD. Since June, Bayview PharmacyMedicine Center Pharmacy and Fletcher Family Medical Center have all voluntarily discontinued claims about compounded semaglutide. The NAD reported the conclusion of the Fletcher case one week before sharing details of Regen’s decision to discontinue its claims.

The cases form part of Novo’s push to hit back against semaglutide compounding, which it has presented as a threat to patients and its business alike. David Moore, executive vice president of U.S. operations at Novo, estimated on an earnings call this month that “well above 1 million patients in the U.S.” are currently on a compounded GLP-1 drug.

Competing against compounders and losing market share to Eli Lilly, Novo recently began a limited time offer on Ozempic and Wegovy. U.S. self-pay patients will pay $199 a month for the first two months of most dosages of the meds, after which the monthly price will rise to $349; the starting price of Regen’s compounded semaglutide, which includes a monthly telehealth visit and the drug, is $300

BMO Capital Markets analysts questioned in a note to investors whether Novo’s new self-pay pricing structure is an attempt to crowd out compounders. The analysts noted the new cash-pay price for starter doses of Ozempic and Wegovy is closer to what they have seen from compounders and “well below” the current cash-pay price of Lilly’s Zepbound.