Novo Nordisk Seeks Ban on Unregistered Semaglutide Products in South Africa
Pretoria: Danish drugmaker Novo Nordisk is heading to court in South Africa on Wednesday to try to halt the sale of unapproved copies of semaglutide, the key ingredient in its blockbuster weight-loss and diabetes drugs Wegovy and Ozempic.
Novo Nordisk South Africa filed a High Court application seeking to prevent local compounding pharmacy iDexis from manufacturing, advertising, distributing and selling "unregistered and untested" weight-loss products containing semaglutide base, pending the court's consideration on the matter.
"Our concerns relate to patient safety, product quality and regulatory oversight," Novo said in a statement.
Compounding, the practice of mixing or altering drug ingredients for individual patients, is tightly restricted in South Africa and not permitted for large-scale manufacturing or sale of unregistered medicines - a legal boundary central to the case underway in the High Court in Pretoria.
The compounder, iDexis, has rejected Novo's claims as "scandalous" and unsubstantiated, and has asked the court to compel the company to produce evidence supporting its allegations, according to court filings seen by Reuters.
BROADER PUSHBACK AGAINST COMPOUNDED SEMAGLUTIDE
Novo's legal action reflects a broader push by drugmakers to curb compounded versions of GLP-1 drugs. In the United States, Novo has taken action against pharmacies and telehealth platforms offering copies of semaglutide, arguing they circumvent regulatory safeguards and pose safety risks.
GLP-1 drugs, widely used for diabetes and weight loss, saw demand surge in South Africa last year following the launch of Eli Lilly's blockbuster Mounjaro and subsequently Novo's Wegovy.
The cost for the lowest injected dose of Wegovy has dropped from 3,090 rand ($183) to 1,873 rand, while the cost of the highest dose has fallen 27% to 3,746 rand.
Unable to afford the drugs, some patients switched to compounded copies of the medication, opening up 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 found iDexis was producing GLP-1 medicines, including tirzepatide, for broader commercial distribution - beyond what regulations allow.
Inspectors cited serious deficiencies in quality, safety and compliance. Authorities seized products and ordered a recall of medicines distributed via healthcare providers and pharmacies.
"Unlawful manufacturing, promotion and distribution of unregistered GLP-1 medicines for weight loss is a serious violation of the law and a direct threat to public safety," Vincent Tlala, CEO of the SAPC, said.
