Anvisa Registers Ozivy as Brazil’s First Synthetic Semaglutide Analogue

Overview

• Anvisa published the registration of Ozivy Tuesday, making it the first domestically approved synthetic analogue of semaglutide and classifying it as a 'medicamento novo'.
• The drug is approved for adults with type 2 diabetes as a weekly injectable and requires a two-copy medical prescription for sale.
• Commercial launch cannot occur until the Câmara de Regulação do Mercado de Medicamentos sets a maximum price, a step regulators expect to complete in the coming weeks.
• EMS says it expects to reach pharmacies within about 30 days after price approval, plans an initial supply of roughly 350,000 units, claims production capacity up to 40 million pens a year and proposes a list price about 30% below Ozempic.
• Regulators and industry note key differences from the reference product: Ozivy must be refrigerated before and during use, it is not automatically interchangeable with Ozempic, and wider formal supply is seen as a way to curb a large informal market for GLP‑1 pens while any SUS inclusion would require Conitec and Ministry of Health approval.