The National Health Surveillance Agency (Anvisa) has included Ozivy, a domestically manufactured semaglutide-based drug, in the List of Reference Medicines (LMR). This determination, published in the Friday (10) edition of the Official Gazette of the Union, designates the pharmaceutical as the official quality standard for the development of future generic and similar versions in Brazilian territory.
Technical Validation of the Drug
The medication, developed by the pharmaceutical company EMS and initially approved in May, shares the same active ingredient as the well-known Ozempic. However, the regulatory agency's action does not constitute a new commercial authorization; it is a technical validation focused on efficacy and safety, which will serve as a mandatory model for other laboratories to adjust their own formulations.
Characteristics of Brazilian Semaglutide
The presentation that is now part of the official list is the injectable solution of semaglutide at a concentration of 1.34 mg/mL. This substance mimics the GLP-1 hormone produced by the intestine, helping to regulate blood glucose levels and promoting greater satiety. Due to these benefits, there is high demand for this type of treatment, whether for weight loss or for diabetes management.
Regulatory Difference from Ozempic
The reason why Ozempic does not assume this reference role lies in legal and regulatory issues. As a biological drug, Ozempic prevents other companies from creating generics, requiring the development of 'biosimilars' under specific rules. In contrast, Ozivy was classified as synthetic semaglutide, allowing it to be included in the list guiding generics.
Impact on the Pharmaceutical Market
This regulatory distinction should boost competition in the billion-dollar market for type 2 diabetes control and weight loss. By offering a defined national parameter, the decision facilitates local pharmaceutical industry to present lower-cost copies, intensifying rivalry against multinational giants such as Novo Nordisk (Wegovy) and Eli Lilly (Mounjaro).
Warning to Patients
Despite the potential improvement in access to these therapies with the new regulatory assessment, specialists warn about the need for extreme caution in using these substances. Due to having limited clinical indications and potential adverse effects, constant medical monitoring and the requirement for a medical prescription must be maintained to ensure patient protection.
