South Africa regulator reviews 12 generic semaglutide applications

• SAHPRA has 12 generic semaglutide applications under review but has not disclosed applicant names or approval timelines
• Sun Pharmaceutical Industries received the first approval last week to manufacture and sell generic semaglutide in South Africa
• Novo Nordisk is responding to competition by launching a more affordable authorized copy of Ozempic through a partnership with Acino and cutting Wegovy prices

Summary: South Africa Regulator Reviews Generic Semaglutide Applications

South Africa's health regulator SAHPRA is reviewing 12 applications for generic versions of semaglutide, the active ingredient in Novo Nordisk's blockbuster drugs Ozempic (diabetes) and Wegovy (weight loss). This follows the expiration of Novo's semaglutide patent in South Africa this year.

Key Developments:

• India's Sun Pharmaceutical Industries became the first company to receive SAHPRA approval to manufacture and sell generic semaglutide in South Africa last week
• SAHPRA has not disclosed the names of the 12 applicants or approval timelines
• The influx of generic applications signals potential market disruption in the fast-growing GLP-1 segment

Market Implications:

Additional generic approvals could significantly lower treatment costs and intensify competition in the GLP-1 market, currently dominated by Novo Nordisk and U.S. rival Eli Lilly. Both companies already face growing competition from compounded versions of these medicines globally, with South African regulators actively monitoring the compounded-drug market amid strong demand for affordable alternatives.

Competitive Response:

Novo Nordisk is launching a more affordable authorized copy of Ozempic in South Africa this month through a partnership with healthcare company Acino to expand patient access. The company has also reduced Wegovy's price to improve accessibility.

The patent expiration in South Africa creates a precedent that could influence generic competition in other markets, potentially reshaping the lucrative diabetes and weight-loss drug landscape where demand continues to surge amid supply constraints and high prices.