Drugmaker Fights Unapproved Copycats in South Africa

Danish pharmaceutical company Novo Nordisk is pursuing legal action in South Africa to prevent the sale of unapproved versions of semaglutide, the active ingredient in its popular diabetes and weight-loss medications Ozempic and Wegovy. The company's South African subsidiary has filed a High Court application in Pretoria, seeking to stop iDexis, a local compounding pharmacy, from producing, advertising, and distributing "unregistered and untested" semaglutide-based products.

Novo Nordisk has expressed concerns regarding patient safety, product quality, and regulatory oversight. Compounding in South Africa is strictly regulated and does not permit the large-scale manufacturing or sale of unregistered medicines. iDexis has reportedly dismissed Novo's allegations as unsubstantiated and has requested the court to compel Novo Nordisk to provide supporting evidence.

This legal battle is part of a wider effort by drug manufacturers to combat compounded versions of GLP-1 drugs, including semaglutide. In the United States, Novo Nordisk has previously taken action against pharmacies and telehealth platforms selling copies of semaglutide, citing potential safety risks and circumvention of regulatory standards. The demand for GLP-1 drugs, used for diabetes and weight management, surged in South Africa following the launch of Mounjaro and Wegovy. Due to high costs, some patients have turned to compounded alternatives, creating a gray market. A joint inspection by regulatory authorities found iDexis producing GLP-1 medicines for commercial distribution beyond legal limits, leading to product seizure and recall orders due to identified deficiencies in quality and safety.