Brazil’s National Health Surveillance Agency (Anvisa) has approved the sale of Ozivy from local major drugmaker EMS, which is controlled by the Grupo NC holding. It will be the country’s first analogue of injectable semaglutide for the treatment of adults with type 2 diabetes as an adjunct to diet and exercise. The original drug from Danish company Novo Nordisk lost patent protection in Brazil in March 2026. EMS plans to sell Ozivy at 30% below Ozempic’s price and launch it within 30 days.
Production will be carried out at EMS’s plant in São Paulo state. In the first phase, the company will produce 350,000 pre‑filled pens in dosages of 0.25 mg, 0.5 mg and 1 mg – the last of which accounts for about 60% of the Brazilian market. In the first year, EMS expects to sell 1.2 million units and generate revenue of more than 500 million reais (approximately $100 million). The company added that the active pharmaceutical ingredient will be supplied from China, while pen assembly will be done locally.
Anvisa is currently reviewing five more applications for synthetic semaglutide and one for a biologic version. EMS’s competitor Hypera also plans to launch its own version by the end of the year.
The approval marks a significant milestone for Brazil’s pharmaceutical industry, as local manufacturers seek a share of the fast-growing GLP-1 drug market. In April, Anvisa rejected three applications from Indian companies for generic registration, ruling that they had not demonstrated efficacy, safety and quality.
The original Ozempic is beginning to face generic competition worldwide as Novo Nordisk loses patent protection on its key ingredient, semaglutide, in some markets. India was the first to launch semaglutide generics in March, forcing the Danish drug giant to cut prices there. Last month, generics of the popular drug were also approved in Canada. In the United States and Europe, patent protection will remain for several more years.
