Brazil greenlights five new injectable diabetes drugs

The approvals follow an accelerated initiative launched by Anvisa to clear registration backlogs for semaglutide and liraglutide treatments. To date, the regulator said it has completed reviews for 11 of 24 candidate therapies, resulting in six total approvals after clinical trials, document reviews, and factory inspections.

The first synthetic semaglutide pen was greenlighted by Anvisa in May, with the registering of EMS's drug Ozivy.

Brazil's health regulator Anvisa on Wednesday said it approved five new injectable GLP-1 drugs for diabetes and obesity treatment, capitalizing on a wave of expedited regulatory reviews following the expiration of Ozempic’s patent in the country in March.

The newly authorized medications — Owozy, Seemasun, Zempneo, Semavy, and Orsema — all use synthetically obtained semaglutide as their active ingredient. According to Euromonitor, Latin America's largest economy has seen a massive surge in weight-loss pens penetration, outperforming the regional market average.

Authorized based on clinical comparisons to Ozempic, these injectables are cleared alongside diet and exercise for adult patients who cannot tolerate metformin, the standard oral tablet for diabetes, Anvisa said in a statement.