Brazil Clears First Domestic Semaglutide Pen and Sets Price Ceiling Equal to Ozempic

Overview

• Anvisa approved EMS’s Ozivy on Tuesday, May 26, authorizing the first Brazilian semaglutide pen to be commercialized.
• The drug regulator’s pricing body CMED placed Ozivy in “category 4” and set maximum consumer prices equal to Ozempic: R$1,077.79 for 1.5 ml and R$1,399.72 for 3 ml before state ICMS taxes.
• EMS says it will price Ozivy about 30% below the foreign reference and will announce the final market price and pharmacy arrival date soon, targeting availability in roughly two to three months.
• New entries will be staggered because Anvisa will grant at most three semaglutide authorizations per semester and injectable production requires costly sterile lines and cold‑chain logistics that only a few Brazilian firms currently have.
• Patients may see modest near‑term price relief from commercial discounts but analysts expect larger reductions over years, and higher‑generation drugs such as tirzepatide remain patent‑protected until later, keeping the most effective alternatives off the immediate market.