# Semaglutide regulatory approvals and pricing in Brazil

> Live situation record from CLSTR: https://clstr.news/situations/semaglutide-regulatory-approvals-in-brazil
> Updated: 2026-08-24T11:30:07.000Z. Sources: 79. Developments: 4.

Brazil’s National Health Surveillance Agency (Anvisa) has expanded the domestic market for semaglutide, a medication used to treat type 2 diabetes and weight loss. Initially, Anvisa registered five new semaglutide injectable pens—Owozy, Seemasun, Zempneo, Semavy, and Orsema—for adults with inadequately controlled type 2 diabetes. These products were approved via comparison with the reference biologic Ozempic and are assigned to various companies including Ávita Care and Sun Farmacêutica. Because these were not classified as generics, automatic pharmacy substitution does not apply.

Following these registrations, Anvisa approved the country’s first generic and similar versions of the medication. EMS received registration for a generic version named Ozivy, which utilizes a synthetic version of the active ingredient and includes four different injectable pen presentations of 1.34 mg/mL in various pen and kit configurations. Additionally, Germed received approval for a similar version of the drug to be sold under the name Semaclique.

Following the expiration of the substance's patent in March 2026, the market has seen further regulatory milestones. Anvisa recently approved the registration of a second generic version of semaglutide, granted to Germed Farmacêutica. This follows the EMS generic approval by just one week. The new Germed generic will be available in four injectable presentations and is expected to be priced at least 35% lower than reference products like Ozempic and Wegovy. In response to increased competition, Eurofarma has announced price reductions of up to 39% for its Poviztra product for patients enrolled in its EuroCuida support program.

## Claims

- Anvisa approved the first generic semaglutide medication in Brazil. (disputed by 29 sources)
- Semaclique is the second generic semaglutide pen approved in Brazil. (disputed by 4 sources)
- The registration for the generic semaglutide was granted to the pharmaceutical company EMS. (corroborated by 29 sources)
- Anvisa approved a similar semaglutide medication from Germed, to be sold under the name Semaclique. (corroborated by 29 sources)
- Semaglutide is used to treat type 2 diabetes and obesity. (corroborated by 24 sources)
- Generic medications in Brazil must be priced at least 35% lower than the reference drug. (corroborated by 20 sources)
- The semaglutide pens must be stored in a refrigerator at temperatures between 2 °C and 8 °C. (corroborated by 9 sources)
- The use of synthetic semaglutide requires a medical prescription in two copies. (corroborated by 8 sources)
- The approved EMS registration includes four presentations of 1.34 mg/mL in pens or kits with varying volumes and needle counts. (corroborated by 5 sources)

## Timeline

### 2026-08-24: Anvisa approves second generic semaglutide in Brazil

Anvisa has approved Germed Farmacêutica's semaglutide generic in Brazil, increasing competition for diabetes and obesity treatments following the expiration of original patents.

21 sources. https://clstr.news/cluster/anvisa-approves-second-generic-semaglutide-in-brazil

### 2026-08-21: Eurofarma reduces prices for semaglutide medication Poviztra

Eurofarma has reduced prices for its semaglutide-based obesity medication, Poviztra, by up to 39% in Brazil as competition increases following patent expirations.

3 sources. https://clstr.news/cluster/eurofarma-reduces-prices-for-semaglutide-medication-poviztra

### 2026-08-17: Anvisa approves Brazil's first generic semaglutide medication

Anvisa has approved Brazil's first generic semaglutide medication from EMS and a similar version from Germed, named Semaclique, for treating type 2 diabetes.

64 sources. https://clstr.news/cluster/anvisa-approves-first-generic-and-similar-semaglutide-in-brazil

### 2026-07-29: Brazil's Anvisa approves five new semaglutide injection pens

Brazil's Anvisa registered five semaglutide injection pens (Owozy, Seemasun, Zempneo, Semavy, Orsema) for type‑2 diabetes, marking the largest GLP‑1 agonist approval batch and expanding market competition.

11 sources. https://clstr.news/cluster/brazils-anvisa-registers-five-semaglutide-pens-for-type2-diabetes-treatment

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Cite as: Semaglutide regulatory approvals and pricing in Brazil. CLSTR, https://clstr.news/situations/semaglutide-regulatory-approvals-in-brazil