Anvisa aprova 5 novas canetas para tratamento da obesidade; veja quais

The authorizations were published in the Official Gazette of the Union (DOU) and are valid for the following products:

Orsema, from Ranbaxy; Owozy, from Ávita Care; Seemasun, from Sun Pharma; Semavy, from Cosmed; Zempneo, from Brainfarma. Anvisa reported that the medicines were registered in comparison with the reference product Ozempic and are indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus.

“The new injectable devices have been authorized for use in addition to diet and exercise when the use of metformin is considered inappropriate due to patient intolerance or contraindications,” the agency said.

In the resolution, the products were registered as “new medicine (new Active Pharmaceutical Ingredient — IFA — analogue)”, through the “abbreviated development route”, a regulatory modality intended for medicines that use an already known active ingredient and for which part of the scientific evidence can be used, as long as the company proves the quality, safety and efficacy of the product.

The approved presentations consist of injectable solutions for subcutaneous application, accompanied by an applicator pen and needles.

In August last year, Anvisa began to prioritize the analysis of medicines based on semaglutide and liraglutide, due to a request from the Ministry of Health and the need to supply the national market. To this end, a call for proposals was published.

At the same time, the agency put into practice an action plan with 125 initiatives to reduce the queues for granting medication registrations and reduce the time it takes to analyze these requests.

“This mobilization was decisive in accelerating the approval process for new pens: 11 of the 24 synthetic and biological medicines included in the notice have already had their analysis completed, resulting in six approved medicines,” said Anvisa.

According to the agency, the evaluation process includes carrying out clinical studies, analyzing documentation and inspecting the sterile production line.

The agency added that the increase in the number of registration applications is related to the development of synthetic versions of the natural hormone GLP-1 and the expiration of patents on some medicines in recent years.

Scammers make videos of celebrities with AI to sell medicines on social media, warns Anvisa

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