0:00Access to weight loss and diabetes medicines like Ozempic and Mounjaro is set to expand once generic versions are approved for sale.
Peter Dazeley/

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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 in March 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.

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 market dominated by Novo and US rival Eli Lilly, which manufactures Mounjaro.

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.

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.

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