Medicine should be sold from the second half of the year, 30% cheaper than the original
O Revivesmedicine from the EMS laboratory, was the first synthetic semaglutide-based authorized for manufacturing in Brazil by the National Health Surveillance Agency (Anvisa), which . The slimming pen uses the same active ingredient as Ozempica drug from the Danish pharmaceutical company Novo Nordisk for the treatment of type 2 diabetes, which was famous for helping with weight loss.
The famous ones belong to a class of medicines called GLP-1 receptor agonistswhich now has an open market for production orders in Brazil, . Anvisa analyzes requests from pharmaceutical companies to evaluate quality, safety and effectiveness of new Brazilian GLP-1 medicines.
With the Ozempic’s patent fallafter reaching the maximum period of 20 years of exclusivity provided for by Brazilian law, , but until now only Ozivy got authorization. Currently, another five medicines of synthetic origin and one of biological origin from semaglutide are still being analyzed by the Agency, in addition to other processes that are in the queue.
Revives
According to the surveillance agency, Ozivy is not considered a generic medicinebut rather a new medicine synthetic analogous to a biological productindicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus, as an adjunct to diet and exercise.
The product will be presented as injectable solution, in pre-filled pen for weekly administration. The way the new product is stored is different from the Ozempic medication, requiring it to be stored stored at temperatures of 2°C to 8°C during treatment. The original medicine requires this care only before use, and can be kept out of the refrigerator, up to 30 ºC, for up to six weeks after the patient starts using it.
To date, Anvisa has approved four models presentation for Ozivy:
- Semaglutide 1.34 mg/mL injectable solution in prefilled application system (multidose and disposable) with 1.5 ml + 1 pen + 6 needles
- Semaglutide 1.34 mg/mL injectable solution in prefilled application system (multidose and disposable) with 3 ml + 2 pens + 10 needles
- Semaglutide 1.34 mg/mL injectable solution in prefilled application system (multidose and disposable) with 1.5 ml + 1 pen + 4 needles
- Semaglutide 1.34 mg/mL injectable solution in prefilled application system (multidose and disposable) with 3 ml + 2 pens + 8 needles
Marketing
The Minister of Health, Alexandre Padilha, stated in interview with the program Tempo Real, on Jovem Panthis Tuesday (26), that, despite approval by Anvisa, the drug Ozivy will not have. “The expectation is that in the beginning of the second semester it is already in pharmacies with a lower price.”
Padilha added that the price of Ozivy, in addition to being cheaper because it is a generic medicine, may be even lower. “Normally, generic medication is at least 30% cheaper. But, as we believe that, in addition to this, others will come, there are 17 more that we are analyzing, we will have a good competition in the market that will bring this value down even further”.
The Generics Law (Law No. 9,787) determines that the factory price of Generic medicine must be at least 35% cheaper than the ceiling for the original medicine brand, as laboratories do not need to bear the costs of research to develop the drug from scratch or advertising, as they use the active ingredient as a trade name.
Regarding the supervision of originality of the medicinewith many people buying the “pens” abroad, Padilha says it will be done in two ways, by Anvisa and the Federal Police. “Unfortunately the people are putting their own health at riskbuying pens from other countries, without the correct origin. So let’s go inspect establishments, compounding pharmacies and at the border”.
With authorization from Anvisa, the next step for the medicine to be commercialized is the approval of the maximum price by the Medicines Market Regulation Chamber (CMED). EMS, the company that holds the registration, however, decides when the medicine will go on sale.
Caneta not SUS?
According to Anvisa, for the product to be available in the Unified Health System (SUS), it needs to be evaluated and recommended by the National Commission for the Incorporation of Technologies into the SUS (Conitec) and approved by the Ministry of Health. It is worth remembering that not all medicines registered with Anvisa undergo Conitec evaluation or are incorporated into the SUS.
Regarding use in the public health system, minister Alexandre Padilha said that a study for approval is being carried out. “We, at the Ministry of Health, are starting a protocol for analysis of the use of this type of medication in the SUS. Many people end up using this medicine for aesthetic reasons, so it is important that we have this regulated”, he added.
According to the minister, it is also necessary to monitor how people will use the medicine in their homes. “Anvisa requires you to have a medical prescription and a copy as well. From time to time, conditions of use are monitored”, he concludes.
*with information from Estadão Conteúdo
