The medicine is a synthetic version of the same active ingredient as Ozempic, which had its patent overturned in the country in March this year.
A National Health Surveillance Agency (Anvisa) approved this Tuesday (26) the registration of the Ozivy medicinethe first synthetic semaglutide pen authorized for sale in Brazil. The product uses the same active ingredient of Ozempic and was developed by the EMS laboratory.
Approval comes after Ozempic’s patent expiresexpired in March this year. According to Anvisa, the medicine underwent technical analyzes of efficacy, safety and quality before receiving authorization for sale in the country.
Ozivy has been approved for treating adults with type 2 diabetesassociated with diet and physical exercise. The medication can be used either alone, in cases where metformin is not indicated, or combined with other treatments for diabetes.
The new pen will be applied weekly and will have different storage than the Ozempic. The product must remain refrigerated between 2 °C and 8 °C throughout the period of use.
Anvisa also informed that Ozivy is not considered a generic medicine, but rather a new synthetic medicine analogous to a biological product. Currently, other six requests involving semaglutide remain under analysis by the agency.
See the approved presentation options:
-Injectable solution of semaglutide 1.34 mg/mL in prefilled application system (multidose and disposable) with 1.5 ml + 1 pen + 6 needles
-Injectable solution of semaglutide 1.34 mg/mL in prefilled application system (multidose and disposable) with 3 ml + 2 pens +10 needles
-Injectable solution of semaglutide 1.34 mg/mL in prefilled application system (multidose and disposable) with 1.5 ml + 1 pen + 4 needles
-Injectable solution of semaglutide 1.34 mg/mL in prefilled application system (multidose and disposable) with 3 ml + 2 pens + 8 needles
Technical challenge
In a note, Anvisa also stated that the evaluation of medicines based on synthetic semaglutide represents a technical challenge for regulatory agencies around the world. Brazil is among the first countries to approve this type of product.
Until then, semaglutide medicines registered in the country were exclusively biological. Unlike them, synthetic analogues are produced by chemical synthesis, which allows greater stability and standardized reproduction of the molecules.
Despite this, these products are considered high complexity as they combine characteristics of synthetic and biological medicines.
When can Ozivy be sold in Brazil?
Despite Anvisa’s approval, Ozivy still There is no set date for it to hit the market. Before commercialization, the medicine must have the maximum price approved by the Medicines Market Regulation Chamber (CMED). After this stage, it will be up to the responsible laboratory to decide when the product will be put on sale.
For a possible offer in the Unified Health System (SUS)the medicine still will need to undergo evaluation by the National Commission for the Incorporation of Technologies into the SUS (Conitec) and receive approval from the Ministry of Health. Anvisa emphasizes that not all registered medicines are incorporated into the public network.
Ozempic patent has expired
A opening space for other pharmaceutical companies to develop competing medicines based on semaglutide, used to treat type 2 diabetes and also for weight loss.
At the time, the manufacturer Novo Nordisk stated that the end of the patent is “part of the natural cycle of innovation in the pharmaceutical industry” and said it was prepared to act in the new market scenario.
