The approvals follow an earlier regulatory clearance in Canada in July, giving Aspen access to three markets ahead of planned commercial launches in the coming months. According to the company, the medicine is indicated for adults with type 2 diabetes and is used alongside diet and exercise to improve blood sugar control.
Semaglutide is the active ingredient in Novo Nordisk’s Ozempic, a medicine widely used to manage type 2 diabetes. It also features in Wegovy, which is approved for weight management in eligible patients.
Aspen is positioning generic semaglutide as part of its strategy to expand in the global market for GLP-1 medicines, a class of drugs that has attracted growing demand for diabetes and weight-management treatment.
The loss of patent protection in several markets has opened opportunities for manufacturers to develop lower-cost generic versions, increasing competition among pharmaceutical companies.
Aspen said it expects to begin commercialising its product in Canada, Brazil and South Africa over the next few months. It has also indicated that regulatory applications are pending in approximately 20 other countries.
The development could increase competition in markets where semaglutide-based treatments have become increasingly sought after. However, the actual impact on patient access will depend on launch prices, supply capacity, reimbursement arrangements and the availability of the medicine through healthcare systems.
The approvals mark a significant expansion for an African pharmaceutical manufacturer seeking a larger role in the international market for advanced diabetes treatments.
