Anvisa approves Brazilian weight-loss pen after Ozempic patent expires

Anvisa (National Health Surveillance Agency) approved, this Tuesday (26), the first synthetic semaglutide pen analogous to Brazilian Ozempic. The medicine is called Ozivy and is a synthetic version of the same active ingredient as Ozempic, which had its patent overturned on March 20.

The medicine is manufactured by EMS, which filed the order in 2023 and went through Anvisa's technical process of proving its efficacy, safety and quality.

Ozivy is part of the so-called GLP-1 type medicines and is made from semaglutide, the active ingredient in Ozempic medicines. This category is indicated for the treatment of type 2 diabetes and is popularly known as "slimming pens".

Anvisa emphasizes that Ozivy is not considered a generic medicine, since Brazilian regulation does not provide for the category of "generics" for products of biological origin.

Instead, the drug was classified by the agency as a "new medicine", being technically defined as a synthetic analogue of a biological product.

Although it has already received approval from Anvisa, Ozivy still needs to pass maximum price approval from the Medicines Market Regulation Chamber before reaching pharmacies.

After this stage, it will be exclusively up to EMS to decide the official launch date on the market. The pen's arrival at the SUS will depend on an evaluation and recommendation by the National Commission for the Incorporation of Technologies into the SUS, in addition to approval by the Ministry of Health.

Ozempic generic may arrive in Brazil in 2026; understand

Source: CNN