Aspen Pharmacare, the South Africa–based multinational drugmaker led by billionaire Stephen Saad, has secured regulatory approval in Brazil and South Africa for its generic injectable semaglutide, clearing a major hurdle in its push to capture demand for lower-cost diabetes and weight-loss treatments. The company expects to begin commercial sales in both markets in the coming months.

Semaglutide is the active ingredient in Novo Nordisk’s blockbuster medicines Ozempic, used to treat Type 2 diabetes, and Wegovy, prescribed for weight management. The loss of patent protection in selected markets has opened the door for generic manufacturers to challenge established drugmakers with more affordable alternatives.

Aspen targets growing demand

Aspen is positioning generic semaglutide as a growth driver across emerging markets and selected international territories. The company also expects to commercialize the treatment in Canada, where it is sourcing the active pharmaceutical ingredient from third-party suppliers, including India’s Dr. Reddy’s Laboratories.

The opportunity is underpinned by rising demand for medicines used to treat obesity and diabetes. Aspen estimates South Africa’s GLP-1 drug market has grown to nearly R3 billion ($181.3 million), with Eli Lilly’s Mounjaro accounting for more than half of sales.

Aspen already distributes Mounjaro across sub-Saharan Africa for Lilly, giving it an established commercial presence in a market where demand for GLP-1 treatments is expanding. Its entry into generic semaglutide could broaden its position in the category as competition increases and lower-priced alternatives reach consumers.

Ovestin sale strengthens finances

The regulatory approvals come as Aspen reshapes parts of its international portfolio. On Nov. 3, the company completed the sale of European rights to its women’s health medicine Ovestin to privately owned Ennogen Healthcare International for €197 million ($219.4 million), after the buyer secured unconditional funding.

Ennogen will pay an additional €4 million ($4.4 million) for existing Ovestin inventory. Aspen expects to record a profit of about R2 billion ($120.8 million) from the transaction, while retaining responsibility for manufacturing and supplying the medicine’s active ingredient and cream formulation in Europe for at least 10 years.

Saad expands pharmaceutical business

Founded in 1997 and headquartered in Durban, Aspen has grown into Africa’s largest pharmaceutical manufacturer, with manufacturing and commercial operations spanning several international markets. Listed on the Johannesburg Stock Exchange, the group has expanded beyond its South African roots under Saad, who has led the company since 1999.

Saad owns approximately 13.2% of Aspen, equivalent to 58.8 million shares. The generic semaglutide approvals give the company another opportunity to expand its specialty medicines business as patent expirations create openings for manufacturers targeting the fast-growing global market for metabolic treatments.