Anvisa Registers Five More GLP‑1 Injection Pens

Overview

• Anvisa published the new registrations on Thursday, Oct. 29, approving five GLP‑1 pens, three listed for diabetes (Aribet, Embeltah, Sevema) and two for obesity (Lyrza, Wylovol).
• The records name the registrant companies and manufacturers, with several products registered by Farma Vision, Dr. Reddy's and Aché and multiple batches made by Indian firms such as Biocon and OneSource Specialty.
• These five approvals raise the total number of GLP‑1 pens authorized in Brazil in 2026 to 20, a surge driven by the end of patents for liraglutide in 2024 and semaglutide in March 2026.
• Sanitary registration is only one step toward sales, so the approvals do not set launch dates or guarantee lower prices because final commercial timing and maximum prices are determined by manufacturers and the CMED regulator.
• Regulators keep sales controlled for safety: since 2025 pharmacies must retain a medical prescription for GLP‑1 agonists, and the approvals were fast‑tracked under Edital de Chamamento nº 12/2025 at the Ministry of Health's request to broaden supply and potential SUS access.