Aspen Pharmacare has received regulatory approval for its generic injectable semaglutide in Brazil and South Africa, paving the way for launches in two key emerging markets.
The South African drug maker announced the approvals on Wednesday, following an earlier regulatory approval in Canada in July. It expects to begin commercialising the product across all three countries over the next few months.
The announcement marks another step in Aspen’s plans to build its business around generic versions of semaglutide as patent expiries create opportunities for new competitors.
Semaglutide is the active ingredient in Novo Nordisk’s diabetes medicine Ozempic and weight loss treatment Wegovy. Aspen is targeting emerging markets and selected international markets with its generic version as competition for the molecule grows.
According to the company’s regulatory announcement, its injectable treatment is indicated for adults with type 2 diabetes to improve glycaemic control, in combination with diet and exercise.
The announcement therefore centres on diabetes treatment, with Aspen’s stated indication distinct from the weight management use that has helped drive wider interest in semaglutide.
Aspen did not provide specific launch dates or pricing in the announcement, leaving the timing of patient access and the potential cost difference from existing treatments unclear.
The approvals come as demand for diabetes and obesity medicines continues to shape South Africa’s pharmaceutical market.
According to Aspen, sales of GLP-1 medicines in the country have grown to nearly 3bn rand, approximately $182m. Eli Lilly’s Mounjaro accounts for more than half of that market.
Aspen already distributes Mounjaro in sub-Saharan Africa, giving it an existing role in the region’s expanding diabetes and weight management business.
For its generic semaglutide, the company is sourcing the active pharmaceutical ingredient from third-party suppliers, including India’s Dr. Reddy’s Laboratories for the Canadian market.
Aspen has previously highlighted pending semaglutide registrations across additional emerging markets as part of its growth plans. The latest approvals bring two of those markets closer to commercial launch, expanding the company’s opportunities beyond its Canadian registration.
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