Pretoria – Danish drugmaker Novo Nordisk moved to court in South Africa on Wednesday to stop the sale of unapproved copies of semaglutide, the active ingredient in its blockbuster weight loss and diabetes drugs Vegovy and Ozempic.
Novo Nordisk South Africa has filed a High Court application seeking to stop local compounding pharmacy Idexis from manufacturing, advertising, distributing and selling “unregistered and untested” weight loss products containing a semaglutide base pending the court's consideration of the case.
“Our concerns relate to patient safety, product quality and regulatory oversight,” Novo Nordisk said in a statement.
The practice of mixing or substituting drug ingredients for different patients is strictly prohibited in South Africa. Large-scale manufacturing or sale of unregistered drugs is not allowed – a legal limit central to the case being heard in the High Court in Pretoria.
The arguments from legal representatives of both companies also concern whether the active ingredient used by iDexis, responsible for the drug's therapeutic effect, is exactly the same or similar to semaglutide, which would need to be registered for approval to be sold legally.
Stefan Maritz, a senior lawyer representing IDexis, said Compounder, IDexis, rejects Novo Nordisk's claims as baseless, and has asked the court to force the company to present evidence in support of its allegations.
They also said there have been no reports of adverse reactions or conditions from the use of iDexis products.
The judge has not yet ruled and said he would do so as soon as possible.
Widespread resistance against mixed semaglutide
Novo Nordisk's legal action reflects a broader effort by drugmakers to curb compounded versions of GLP-1 drugs. In the United States, Novo Nordisk has taken action against pharmacies and telehealth platforms offering copies of semaglutide, saying they circumvent regulatory safeguards and pose a safety risk. Demand for GLP-1 drugs, widely used for diabetes and weight loss, surged in South Africa last year following the launch of Eli Lilly's blockbuster Monzaro and then Novo's Wegovi. The price of the lowest injectable dose of Wegovi fell to 1,873 rand from 3,090 rand ($183), while the price of the highest dose fell 27% to 3,746 rand.
Unable to purchase the drugs, some patients began using adulterated copies of the drug, opening a gray market for many pharmacies and local producers.
A joint inspection by the South African Health Products Regulatory Authority and the South African Pharmacy Council last month found that iDexis was producing GLP-1 drugs, including tirazepide, for wider commercial distribution – beyond what is allowed by regulations.
Inspectors cited serious deficiencies in quality, safety and compliance. Authorities seized the products and ordered the recall of the drugs distributed through healthcare providers and pharmacies. “The illegal manufacturing, promotion and distribution of unregistered GLP-1 drugs for weight loss is a serious violation of the law and a direct threat to public safety,” SAPC CEO Vincent Tlala said.
iDexis said at the time that its compounding processes complied with legal requirements and that it would defend itself in court.