Aspen, controlled by tycoon Stephen Saad, wins Canadian approval for generic Ozempic

Aspen Pharmacare, the drugmaker built by South African billionaire Stephen Saad, has won Health Canada approval for a generic version of Novo Nordisk's diabetes blockbuster Ozempic, though a supply failure at its ingredient partner will keep the product off Canadian shelves for months.

The company said on Monday that its Canadian subsidiary had received regulatory clearance for Aspen-Semaglutide, authorised for the management of type 2 diabetes. Africa's largest pharmaceutical company had been racing to be among the first generic manufacturers into the market after Novo's patent protection lapsed.

The approval alone does not put the drug into pharmacies. Aspen said the timing of its commercial launch depends on securing semaglutide active pharmaceutical ingredient from India's Dr Reddy's Laboratories. That supply is not coming soon. Dr Reddy's said earlier this month that its generic semaglutide would remain unavailable in India and face disruptions in Canada until at least late October, after an impurity in the active ingredient halted production of new batches.

A race Saad set out to win

Saad, Aspen's chief executive, had targeted this outcome publicly. He told Reuters in March that the company expected registration in Canada between May and September, and said Aspen hoped to be among the first to provide generic competition to Ozempic there.

The strategy extends beyond a single market. Saad has said Canadian approval matters because other national regulators treat Health Canada as a benchmark, meaning clearance there can accelerate applications elsewhere. Getting in early was the point.

He also set out where the medicine would be made. Aspen will manufacture its generics at plants in South Africa and France, with the South African site handling larger volumes of multi-dose pens and the French facility producing single-dose autoinjectors.

A crowded field

Novo's regulatory exclusivity on semaglutide expired in Canada on January 4, opening one of the first major markets anywhere to generic competition on a drug class that has reshaped the pharmaceutical industry. Semaglutide is the active ingredient in both Ozempic, prescribed for diabetes, and Wegovy, prescribed for weight loss.

Aspen is not alone. Sandoz Canada, Apotex, Teva Canada and Taro Pharmaceuticals have all filed for Health Canada approval of their own generic versions, and the regulator has been weighing nine submissions.

Novo has moved to defend its position from inside. Health Canada approved the Danish company's submissions for Plosbrio and Poviztra in December, renamed and lower-priced versions of Ozempic and Wegovy that are identical in formulation, differing only in name and packaging.

Approval of the generics has been slow because the assessment is technically complex. Novo's products were developed using biological processes, while the generic versions are made by chemical synthesis, and manufacturers must demonstrate that the differences do not affect safety, efficacy or quality.

The company Saad built

Saad co-founded Aspen in 1997 with Gus Attridge, acquiring a small South African generics business and building it into a group operating across more than 50 countries with manufacturing sites in Africa, Europe, Latin America and Asia-Pacific. It became the largest pharmaceutical company on the continent and one of the biggest suppliers of generic medicines in emerging markets.

His fortune is tied to his holding in the Johannesburg-listed group, which he has led as chief executive throughout. The GLP-1 opportunity is among the largest the company has pursued, given the scale of global demand for the drug class and the premium pricing that generic entry is expected to erode.

Whether Aspen captures early market share now rests on a factor outside its control. The company holds the approval it wanted, in the market it targeted, on roughly the timetable Saad predicted. It cannot sell the product until an Indian supplier resolves a manufacturing fault.