JOHANNESBURG, July 15: India’s Sun Pharmaceutical Industries has received approval from South Africa’s health regulator to manufacture and sell a generic version of semaglutide, the active ingredient in Novo Nordisk’s top-selling diabetes and obesity drugs.
Novo’s patent on semaglutide – used in diabetes drug Ozempic and weight-loss treatment Wegovy – expired in March, prompting expectations of a wave of cheaper generics from local and international drugmakers.
The entry of generics also poses a challenge to U.S. company Eli Lilly, which has launched blockbuster diabetes and obesity drugs in South Africa as well.
The approval from the South African Health Products Regulatory Authority makes South Africa the second market, after India, where Sun Pharma has secured clearance for a generic semaglutide injection, the company said in a statement.
The approval is for adults with inadequately controlled type 2 diabetes.
Sun Pharma said it plans to launch the product in South Africa in the coming days. The drug will be sold as a pre-filled, multi-dose injectable pen in two strengths — 2 mg and 4 mg — for once-weekly use.
“We remain committed to improving access to generics and making evidence-based treatment options available to patients and healthcare professionals,” said Sun Pharma’s Chief Operating Officer Aalok Shanghvi.
South Africa’s weight-loss drug market is dominated by Eli Lilly’s Mounjaro and Novo’s Ozempic and Wegovy, although the products face growing competition from compounded versions of the medicines.
Regulators have been increasing efforts to monitor and regulate the compounded-drug market amid strong demand for low-cost treatments.