South Africa’s medicines regulator is reviewing 12 applications for generic versions of semaglutide, a widely used treatment for type 2 diabetes that has also gained global attention for weight management.
The South African Health Products Regulatory Authority (SAHPRA) confirmed that the applications are under assessment as demand for semaglutide continues to grow worldwide.
Semaglutide belongs to a class of medicines known as GLP-1 receptor agonists. It is prescribed to help manage blood sugar levels in people with type 2 diabetes and, in certain formulations, to support chronic weight management.
The review of generic applications could increase the availability of lower-cost alternatives once regulatory requirements are met and patents or other legal protections allow their market entry. Health experts say greater competition in the market could improve access to treatment for patients, particularly in low and middle income countries where affordability remains a significant barrier.
SAHPRA said all applications are being evaluated in line with established regulatory standards to ensure the medicines meet requirements for safety, quality and efficacy before any approval is granted.
The development comes as African countries face a growing burden of noncommunicable diseases, including diabetes and obesity. Public health specialists have emphasized the importance of expanding access to affordable medicines alongside investments in prevention, early diagnosis and long-term disease management.
South Africa has experienced rising demand for GLP-1 medicines in recent years, reflecting global trends that have at times contributed to supply constraints for patients using the drugs to manage diabetes.
The regulator did not indicate when the review process would be completed or whether any of the applications are nearing approval. Decisions will be announced after the scientific assessment and regulatory review have been concluded.
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