Novo Nordisk South Africa is set to launch the country’s first and only authorised copy of semaglutide later this month, a move that could reshape access to one of South Africa’s most sought-after diabetes and weight-management medicines while the legal battle over compounded versions continues.
The pharmaceutical giant announced that the authorised copy, developed in partnership with Acino, will become available on 27 July, offering patients a lower-cost alternative to the original semaglutide without compromising on quality or manufacturing standards.
The launch comes just days after Novo Nordisk secured an interim legal victory against iDexis, with the company arguing that unregistered compounded versions of semaglutide pose regulatory and patient safety concerns. The dispute has become one of the country’s most closely watched pharmaceutical cases, highlighting growing demand for affordable weight-loss medication.
Manufactured by the original producer
Novo Nordisk says its authorised copy differs significantly from compounded products because it is manufactured by the original producer using the same active pharmaceutical ingredient (API), manufacturing process, production lines and injection device as the originator medicine. The product is also registered with the South African Health Products Regulatory Authority (SAHPRA).
According to the company, authorised copies are distinct from generic, compounded or biosimilar medicines because they are exact duplicates of the originator product and rely on the same safety and efficacy data submitted to regulators.
‘Addressing affordability‘
Sara Norcross, General Manager of Novo Nordisk South Africa, said the launch is aimed at addressing affordability while maintaining confidence in the medicine’s quality.
“We are proud to introduce an affordable, authorised semaglutide copy to help broaden access for patients across South Africa. This launch reflects our continued commitment to driving change in the prevention and treatment of serious chronic diseases.”
The announcement is expected to intensify debate around access to GLP-1 medicines, which have seen unprecedented demand globally for the treatment of type 2 diabetes and obesity. High prices and limited availability have fuelled the rise of compounded versions in several markets, including South Africa, prompting increased regulatory scrutiny.
Novo Nordisk’s latest offering appears to be a direct response to those affordability concerns by providing a lower-priced alternative that remains within the regulated pharmaceutical supply chain.
Retail price not yet disclosed
The company has not yet disclosed the retail price but says the medicine is intended to improve access for more South Africans living with type 2 diabetes.
According to the International Diabetes Federation, an estimated 2.3-million South African adults are living with diabetes, representing approximately 7.2% of the adult population, making it one of the country’s leading chronic health challenges.
The launch also marks another significant development in the rapidly evolving semaglutide market, where legal disputes, supply shortages and growing demand have placed access to treatment firmly in the spotlight.
- Novo Nordisk South Africa will launch the country's first authorised copy of semaglutide on 27 July, developed with Acino, offering a lower-cost alternative to the original diabetes and weight-management medicine.
- The authorised copy is manufactured by the original producer using the same API, manufacturing process, and injection device, and is registered with SAHPRA, differentiating it from unregulated compounded versions.
- This launch follows Novo Nordisk's interim legal victory against iDexis, targeting unregistered compounded semaglutide formulations due to safety and regulatory concerns.
- The move aims to improve affordability and access to quality GLP-1 medicines amid rising demand and high prices for diabetes and obesity treatments in South Africa.
- Retail pricing has not been disclosed; however, the launch addresses a critical need as roughly 2.3 million South African adults live with diabetes, highlighting the significance of improving treatment accessibility.
