Aspen Gets Approval for Generic Semaglutide in Brazil and South Africa

Aspen Pharmacare has received regulatory approval for its generic semaglutide injectable in Brazil and South Africa, the JSE-listed drugmaker announced on 11 November 2026. Canada approved the product in July, and Aspen expects commercialization to begin in all three markets over the coming months.

What the generic semaglutide approval covers

The product is indicated for adults with type 2 diabetes. The SENS wording reads: “Semaglutide is indicated, in combination with diet and exercise, for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control.” Business Insider Africa notes that the approval should not be presented as permission to market the product for weight loss, even though semaglutide is used in some branded weight-management products. Aspen’s approvals also do not let it use the Ozempic or Wegovy names, which remain Novo Nordisk trademarks.

Launch details still open

No launch date, commercial name or price has been announced for Brazil or South Africa, and the company has not said who will supply the active ingredient for those markets. For Canada, Dr Reddy’s Laboratories is among the suppliers, according to Business Insider Africa. Aspen’s September results, covered in Syenza’s coverage of Aspen’s September results, tied Canadian timing to API supply and named South Africa, parts of Latin America including Brazil, and the Middle East as first-wave markets.

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Mounjaro and the South African GLP-1 market

South Africa’s GLP-1 medicines market has grown to nearly R3 billion, about US$182 million, with Eli Lilly’s Mounjaro accounting for more than half of sales. Reuters reports those figures as Aspen’s, and they cover the whole GLP-1 category, not Aspen’s expected semaglutide revenue.

Aspen distributes Mounjaro in South Africa and sub-Saharan Africa under an agreement with Eli Lilly. Chief executive Stephen Saad has said he did not expect generic semaglutide to dent Mounjaro demand. Mounjaro contains tirzepatide, which acts on GIP as well as GLP-1 receptors. Semaglutide acts on GLP-1 receptors alone.

Price and competition

Aspen has not disclosed a price in any of the three markets. Syenza’s September coverage reported the company’s aim of pricing generic semaglutide at less than half the originator price. Novo Nordisk has cut Wegovy prices twice in South Africa, most recently in March 2026, for a cumulative reduction of up to 39% since launch. Meanwhile, a Pretoria High Court ruling keeps in force an interim order barring iDexis Compounding Specialists from making semaglutide medicines while two regulators finish their investigations.

What comes next

Aspen’s CEO said recently that the company was awaiting regulatory approval in about 20 countries, according to Business Day. Business Insider Africa describes the Brazil and South Africa decisions as part of a wider expansion strategy rather than the end of the rollout. The commercial brand for either country has not been named yet.

Source: Aspen Pharmacare SENS announcement, 11 November 2026 (JSE: APN), with reporting by Business Day, Business Insider Africa and Reuters.