With the end of protection in Brazil, expectations are for a possible price reduction, but release depends on rigorous evaluation
The National Health Surveillance Agency (Anvisa) currently has eight applications for registration of semaglutide medicines — active ingredient in Ozempic — under analysis, after Friday (20). The expectation with the end of exclusivity is increased competition e possible drop in pricesbut the entry of new medicines into the market is still depends on agency approval.
According to Anvisa, of the eight processes under analysis, seven are synthetic medicines e one of biological origin. Furthermore, other nine orders are still awaiting the start of technical evaluation.
Despite the end of the patent, the agency reinforces that no medicine can be sold in the country without proving effectiveness, security e quality. Therefore, release deadlines are still uncertain.
The majority of requests were submitted in 2025, after Anvisa prioritize the analysis of drugs analogous to GLP-1the class to which semaglutide belongs. Currently, two processes are stopped for technical requirementswaiting for information to be sent by companies by the end of June.
Other requests must have a first decision by the end of Aprilwhich can result in approval, rejection or new requirements.
Difference between types of medicines
The medicines under analysis are divided into two groups:
Biological: produced from living organisms or biotechnological processes, generally more complex and, in many cases, applied by injection;
Synthetics: made by chemical synthesis, with smaller and more stable molecules;
There are also so-called synthetic analogueswho try reproduce the structure of biological medicines. These are considered to be high complexity and demand more detailed assessment.
Rigorous assessment
The analysis of these new medicines is considered a technical challenge around the world. So far, no major international regulatory agency has approved synthetic versions of semaglutide.
This happens because these products combine characteristics of synthetic and biological medicineswhich requires broader testing. Among the main points evaluated are:
- presence of impurities;
- risk of immune system reaction;
- formation of aggregates in the substance;
- guarantee of sterility.
The objective is avoid problems such as adverse reactions or loss of treatment effectiveness.
