Brazil approves EMS's Ozivy, its first generic semaglutide pen

Brazil's health regulator Anvisa said on May 26, 2026 that it approved Ozivy, a semaglutide injector pen made by Brazilian drugmaker EMS, calling it the country's first semaglutide-based injector pen ^[1].

Semaglutide is the active ingredient in Novo Nordisk's Ozempic, which Reuters describes as a diabetes and weight-loss drug. Ozempic's patent expired in Brazil in March, and the Ozivy approval followed ^[1].

EMS plans to produce the pen at a plant in São Paulo state, with capacity for up to 40 million pens a year ^[1]. In March, the CEO of Grupo NC, which controls EMS, told Reuters the company expected to launch semaglutide pens this year ^[1].

The approval does not mean the product is on shelves. Reuters reports Ozivy will be marketed only after Brazil's medicine pricing chamber approves a price cap ^[1]. No price has been disclosed. For the pen to be included in Brazil's public healthcare system, known as SUS, it must also be approved by the Health Ministry, a step that has not been reported as complete ^[1].

Competitors are lining up behind EMS. Anvisa has five other synthetic semaglutide applications and one biological version under review ^[1]. EMS rival Hypera has previously said it also planned to launch its own generic version of semaglutide this year ^[1].

Ozivy is a Brazilian approval only. The Reuters report does not address whether the product will be sold in the United States, and no application for US approval has been reported. The specific conditions Ozivy is cleared to treat in Brazil were not detailed in the report, and neither was a launch date.

Why it matters for patients

For people in the United States taking semaglutide, this approval does not change access to Ozempic, Wegovy or Rybelsus. It does not change US supply, US list prices or US insurance coverage, and no US launch of Ozivy has been reported ^[1]. A decision by Brazil's regulator has no effect on US approvals or on what US pharmacies stock.

Generic or copy versions of a medicine can put downward pressure on prices in the market where they are sold, which is the pattern Brazil is testing after the Ozempic patent expired there in March ^[1]. How much Ozivy would cost in Brazil is not yet known, because the price cap is still pending. Whether public-system patients there would get it is also unresolved until the Health Ministry rules ^[1].

Another detail is unsettled: the report does not say whether Ozivy is approved for weight management, for type 2 diabetes, or for both. Ozempic is described in the report as Novo Nordisk's diabetes and weight-loss drug ^[1], but that description is not a statement about Ozivy's approved uses in Brazil.

What happens next

Brazil's medicine pricing chamber must approve a price cap before Ozivy can be marketed ^[1]. The Health Ministry must approve the product for it to be included in SUS ^[1]. Anvisa is reviewing five other synthetic semaglutide applications and one biological version ^[1]. Hypera has said it planned to launch its own generic semaglutide this year, though no approval for that product has been announced ^[1].