South Africa regulator reviews 12 generic semaglutide applications

Novo's response to the growing competition is the planned launch this month of a more affordable authorised copy of Ozempic in South Africa, through a partnership with healthcare company Acino aimed at expanding patient access. It has also cut the prices of Wegovy to make it more accessible.

Last week, India's Sun Pharmaceutical Industries became the first company to receive approval from SAHPRA to manufacture and sell a generic version in South Africa.

The approval of more generic applications could lead to lower-cost alternatives in South Africa and intensify competition in the fast-growing GLP-1 market dominated by Novo and U.S. rival Eli Lilly.

Like elsewhere in the world, the companies already face growing competition from compounded versions of the medicines. In South Africa, regulators have been stepping up efforts to monitor and regulate the compounded-drug market amid strong demand for lower-cost treatments.

South Africa's health regulator is reviewing 12 applications for generic versions of semaglutide, the active ingredient in Novo Nordisk's blockbuster diabetes and weight-loss medicines, it said on Tuesday.

Novo's patent on semaglutide — used in diabetes drug Ozempic and weight-loss treatment Wegovy — expired this year in South Africa, paving the way for drugmakers to flood the market.

The South African Health Products Regulatory Authority (SAHPRA) said in response to a Reuters query that it has 12 generic semaglutide applications under review but did not provide the names of the applicants or the timelines for potential approval.