EMS’s Ozivy Cleared by Anvisa as First Synthetic Semaglutide Pen After Patent Expiry

Overview

• Anvisa has approved Ozivy for treatment of adults with type 2 diabetes and EMS says it will begin retail sales in mid‑June.
• EMS announced list prices starting at R$452 per pen and an introductory Vida + Leve program that averages R$287 per month for the first three months to lower patient costs.
• The company said it will supply more than 500,000 pens in the initial release and that its Hortolândia plant can produce up to 40 million pens a year.
• Government documents show the trade body Camex granted EMS import‑tax exemptions covering 30 million specialized pen components, with China the largest foreign supplier of those parts.
• Approval does not mean public provision: incorporation into the SUS still requires Conitec and Ministry of Health review and pilot programs with other suppliers continue to inform any decision.