Anvisa approves EMS's version of Ozempic, the first semaglutide produced in Brazil.

Brazil's National Health Surveillance Agency (Anvisa) has approved the first semaglutide slimming pen produced in the country. It will be manufactured by the pharmaceutical company EMS and the medication will be called Ozivy.

The company expects to sell 1.2 million units of the product in the first year, with revenue exceeding R$ 500 million. Now, with the approval, the Sanchez family's company intends to have the pen in pharmacies within 30 days.

The products, which will be manufactured at the Hortolândia plant in the interior of São Paulo state, will be distributed in dosages of 0.25 mg (1 pen); 0.5 mg (1 pen), and 1 mg, with one and two pens. The 1 mg version currently represents 60% of the market.

"For EMS, this moment signifies the greatest achievement in our history from the perspective of research, development, and innovation. A product so eagerly awaited by the medical community and patients will now have a treatment option produced by a Brazilian company," says Marcus Sanchez, Vice President of EMS, in an exclusive interview with NeoFeed.

The first sale will be around 350,000 units, which will uniformly supply pharmacies across the country, including major chains and smaller companies. "We should have them between the end of June and the beginning of July. And distribution will be continuous," he says.

EMS has already invested R$ 1.2 billion in its slimming pen production platform. And, by the end of the year, the company will assess the need for further investments in the Hortolândia factory. "Our factory is ready and sized for the next two years. Now, we will see if we need to make new investments soon. But at least until the end of 2027 we have production capacity," he explains.

The patent for semaglutide in Brazil, held by the Danish company Novo Nordisk, with the brands Ozempic and Wegpvy, expired in March of this year. The company attempted to extend the exclusivity period in court, in its view, to compensate for the lost time, but the Supreme Federal Court (STF) ruled that the 20-year ownership period had been fulfilled.

EMS was also the first to launch the national version of liraglutide, in August of last year, with Olire and Lirux. The patent for the reference drug, also from Novo Nordisk, expired in August 2024.

More information coming soon.