Anvisa prohibits manipulated versions of Ozepic, Mounjaro and Wegovy
Currently, there is no synthetic semaglutide medicine registered in Brazil. Therefore, any manipulation of the substance – biotocnological or synthetic – becomes irregular and illegal, without guarantee of safety or effectiveness. According to Anvisa, until August 6, there were nine requests for registration of synthetic drugs of Semaglutida and seven requests related to liraglutide, all awaiting the beginning of the analysis. In the area of biological drugs, on the same date, there were three processes in process related to liraglutid, semaglutido and combination Icodeca + Semaglutida insulin combination. In this case, the three processes are initial, awaiting distribution for technical analysis.
Production of biotechnological versions of “weight loss pens” uses imported ingredients. Ozepic, for example, mimics the intestinal LPG-1 hormone with the help of genetically modified bacteria and is therefore considered “biotechnological”. Mounjaro and EMS liraglutide (olire and lurux), for example, use synthetic peptides to “assemble” the substance, as explained above.
Anvisa considered that the manipulation of these imported “living ingredients” has a high health risk. In addition, the agency has classified that the technical processes involved are of high complexity, related to the establishment of a “single cell bank system” and a need to ensure the identity, purity, power and stability of IFAS (active pharmaceuticals, such ingredients).
Veto is temporary while a new import procedure is determined for handled. Importing biotechnological ingredients is only allowed for manufacturers who had their products analyzed during the Anvisa registration process, such as New Nordisk Pharmacists (Ozepic, Wegovy and Rybelsus) and Eli Lilly (Mounjaro).
Anvisa also requires quality control tests for ingredients by importers. Pharmacies also have to follow the standards for sterile preparations stipulated by the agency, which should intensify the inspection, according to the order.
What the pharmacists said
In a statement, Novo Nordisk considered Anvisa’s decision “a benefit for public health and the Brazilian patient”. The pharmacist, who currently tries to extend the period of the Patent of Ozepic beyond 2026, spoke of “protection layer against the risks of illegitimately manipulated products.”
