Aug 5 (Reuters) - Danish drugmaker Novo Nordisk
said on Tuesday it has filed 14 new lawsuits in the
United States against the sale of unapproved versions of
semaglutide, the main ingredient in its popular weight-loss and
diabetes drugs, Wegovy and Ozempic.
The new lawsuits target pharmacies and telehealth companies
producing compounded versions of semaglutide "under the fake
guise of personalization", Novo said, without naming the
companies.
Shares of major telehealth firm Hims & Hers
extended losses to fall nearly 13% in afternoon trade. It had
earlier reported weaker-than-expected quarterly revenue.
A Reuters search of legal filings found some cases filed by
Novo in California dated Aug. 4 but none regarding San
Francisco-based Hims.
Hims was not immediately available for comment.
Compounders copy brand-name medicines that are in short
supply by combining, mixing or altering drug ingredients to meet
demand.
These companies were briefly allowed to produce hundreds of
thousands of compounded doses of Novo's obesity and diabetes
drugs when the Food and Drug Administration said they were in
short supply.
When the agency later banned the sale of these copies,
Hims and Hers shifted to creating versions of semaglutide in
personalized doses not accessible through the branded
manufacturers.
Novo's lawsuits allege that telehealth providers violate
state corporate practice of medicine laws by improperly
influencing doctors' decisions and steering patients toward
knockoff compounded "semaglutide" under the guise of
personalized medicine.
In reality, these are knockoffs that have not been
approved as safe and effective and are often made with illicit
foreign active pharmaceutical ingredients (API), Novo said.
It did not immediately respond to a Reuters query on
which companies were being named in the lawsuit.