Anvisa authorises five new semaglutide medicines in Brazil

The Brazilian Health Regulatory Agency (Anvisa) has granted marketing registration to five new medicines containing semaglutide as their active ingredient, increasing the number of manufacturers permitted to sell treatments for type 2 diabetes and obesity in Brazil.

Published in the Official Gazette of the Union on Wednesday (29), the decision marks another stage in the opening of the market following the expiry of the substance’s patent exclusivity in the country.

The authorised medicines are:

• Zempneo (Brainfarma);
• Semavy (Cosmed);
• Orsema (Ranbaxy);
• Seemasun (Sun Farmacêutica);
• Owozy (Ávita Care).

Each product has been registered as a subcutaneous injectable solution supplied in injector pens, a format already familiar to patients receiving this type of treatment.

What is semaglutide?

Semaglutide is part of the GLP-1 receptor agonist class, a group of medicines designed to support blood glucose control in people with type 2 diabetes.

As well as improving blood sugar management, the substance increases the feeling of fullness and slows the rate at which the stomach empties. These effects can reduce food intake and, consequently, support weight loss in patients for whom it is medically indicated.

It has therefore become one of the most widely recognised medicines in recent years, used to treat obesity and excess weight associated with conditions including hypertension, diabetes and dyslipidaemia.

Will the new medicines be available in pharmacies immediately?

Not yet. Anvisa registration means the products are permitted to be marketed in Brazil, provided they complete all the required steps before entering the market.

So far, the companies have not announced official launch dates or the prices they intend to charge. The specific approved indications for each medicine have not been detailed either.

In practical terms, patients will need to wait for the manufacturers’ schedules to find out when the new options will become available.

What will change for people undergoing treatment?

The arrival of additional manufacturers could increase the supply of medicines based on semaglutide.

In recent years, strong demand has caused supply shortages in several parts of the country, while limited availability has also kept prices high.

With more companies authorised to manufacture medicines containing the same active ingredient, the expectation is that the market will become more competitive over time, improving availability for patients.

However, specialists stress that any effect on prices will depend on each laboratory’s commercial strategy and on how quickly the products are launched.

Competition increases after the patent expiry

The latest registrations come only a few months after Anvisa authorised Ozivy, the first domestic competitor to semaglutide to be registered following the end of Novo Nordisk’s patent in Brazil.

Since then, several pharmaceutical companies have invested in products containing the same active ingredient, intensifying competition in a segment worth billions of Brazilian reais worldwide.

According to the regulator, medicines containing semaglutide undergo a stringent assessment covering quality, efficacy, safety, impurity control and the potential for an immune response, owing to the molecule’s complexity.

Are they generic medicines?

Not precisely. Although they contain the same active ingredient, these medicines follow a regulatory route that differs from the one used for conventional generics.

Because semaglutide is regarded as a complex molecule, manufacturers must submit a range of studies showing that their products provide quality, efficacy and safety comparable with those of the reference medicines.

This means that approval requires a more detailed technical review before marketing authorisation can be granted.

Expectations of broader access to treatment

The larger number of manufacturers represents progress in a market that has expanded rapidly in recent years, driven both by rising obesity rates and by demand for more effective type 2 diabetes treatments.

Despite expectations of stronger competition and a possible gradual reduction in prices, it is not yet possible to say when this may happen. Market behaviour will depend on the availability of the new medicines, large-scale production and the commercial strategies adopted by the companies in the coming months.