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South Africa reviews 12 Wegovy alternative applications

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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 Ozempic and Wegovy, 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.

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.

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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