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 diabetes and obesity medicines.
Novo Nordisk’s patent on semaglutide, used in the diabetes drug Ozempic and weight-loss treatment Wegovy, expired in March, paving the way for lower-cost generic alternatives from local and international manufacturers.
The entry of generic products is also expected to increase competition for Eli Lilly, which markets its diabetes and obesity medicines in South Africa.
The South African Health Products Regulatory Authority (SAHPRA) has approved Sun Pharma’s generic semaglutide injection for adults with inadequately controlled type 2 diabetes.
South Africa becomes the second market, after India, where the company has received regulatory approval for the product.
Crackdown on illegal weight loss injectable products
Sun Pharma says it plans to launch the medicine in South Africa in the coming days. The product will be sold as a pre-filled, multi-dose injectable pen in two strengths, 2 mg and 4 mg, for once-weekly use.
Sun Pharma Chief Operating Officer Aalok Shanghvi says, “We remain committed to improving access to generics and making evidence-based treatment options available to patients and healthcare professionals.”
South Africa’s weight-loss drug market is currently led by Eli Lilly’s Mounjaro and Novo Nordisk’s Ozempic and Wegovy, although the products face growing competition from compounded versions of the medicines.
Regulators have stepped up efforts to monitor and regulate the compounded-drug market amid increasing demand for lower-cost treatments.
Following the expiry of Novo Nordisk’s patent in March, several Indian pharmaceutical companies launched generic semaglutide products at prices reported to be up to 80% lower than the original branded medicines.
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