The Brazilian National Health Surveillance Agency (Anvisa) authorized the sale of five new brands of slimming pens on Wednesday, July 29th. Among them was Owozy, a semaglutide pen from Ávita Care .

What should have been a cause for celebration for the importer based in the city of Vinhedo, São Paulo, was met with lament. Ávita submitted its registration request days after EMS , which was the first to receive approval from the regulatory agency.

Therefore, the pharmaceutical market – and the company itself – predicted that Ávita's registration would be approved in early June, which would make it the second semaglutide approved in the country after the expiration of the patents for Ozempic and Wegovy, from Novo Nordisk .

“It’s a two-month delay in the operational launch effort. It’s time we lost. This means more room for competitors. It cost us a significant delay and a loss for society,” says Gisele Pimenta, founder and CEO of Ávita Care, in an interview with NeoFeed .

To give you an idea of what it means to be ahead of the curve, the Ozivy pen from EMS, approved at the end of May, grossed R$ 100 million in the first 15 days of sales. Since the Ávita pen is expected to have a similar price, the company missed out on approximately R$ 400 million in sales.

Ávita's registration with Anvisa (Brazilian Health Regulatory Agency) was made in the name of the European pharmaceutical company Adalvo, which will actually produce the pens. Once the product arrives in the country, its commercialization will be handled by Sandoz.

If the planned schedule had been met, the expectation was that the product would be available on the market in August. With the delay, the trend is that it will not arrive before October (officially, there is still no release date).

“That’s bad. They [competitors] gain market share, build patient loyalty, but patients don’t always switch medication after starting treatment,” says Pimenta.

The current trend is to streamline the import and product promotion process, which will be handled by Sandoz. The company will begin a marketing plan targeting the medical community to ensure the medication is included among doctors' prescription options – this type of product can only be purchased with a prescription.

The “Anvisa factor”

The delay in approving the Owozy slimming pen, from Ávita Care, is related to a kind of "rule change mid-game" on the part of Anvisa (Brazilian Health Regulatory Agency).

The Owozy pen will have the name of Ávita Care, the trademark holder, and Sandoz, which will market it, on its box.

The application to the regulatory agency for approval of the Owozy pen was filed on July 30, 2023. At that time, there was no requirement to submit a certificate of good manufacturing practices for the pharmaceutical ingredient – which, in the case of Ávita, is done in China.

However, two days later, on August 1, 2023, the rules of RDC 359/2020 came into effect. The RDC established the Active Pharmaceutical Ingredient Dossier Adequacy Letter (Cadifa), which made the procedure more rigorous and required the document from the manufacturing plant.

However, Brazilian law does not allow for the retroactive application of a regulatory measure already adopted.

“The process was initiated during a transition period, and under the previous rules. It wasn't mandatory in our case. We didn't need this certification. Even so, we sought this certificate voluntarily. And they didn't carry out the inspection. Anvisa hasn't made any statement about it,” says Pimenta.

In a statement to NeoFeed , Sandoz confirms that, at the time of the registration request, Anvisa did not require a certificate for the IFA (Active Pharmaceutical Ingredient) manufacturing facility.

"The regulations regarding Good Manufacturing Practices certification for Active Pharmaceutical Ingredients were in a period of regulatory transition, and the presentation of this certification was not required for submission," the company states.

The pharmaceutical company added: "Throughout the process, Anvisa (Brazilian Health Regulatory Agency) deemed the presentation of the certification necessary." Sandoz also stated that the new requirement had no bearing on the quality, safety, or efficacy of the medication.

On August 27 of this year, two days before the registration was approved, Anvisa signed a commitment agreement with Ávita, giving them three years to present the certificate of good manufacturing practices for the Chinese API (Active Pharmaceutical Ingredient).

“What many people in the sector didn’t understand is why this document wasn’t signed beforehand so that the approval could have come out together with EMS’s. If they released it without the IFA factory certificate, then there was a real waste of time,” says a pharmaceutical industry source interviewed by NeoFeed .

According to Anvisa's website, both EMS's and Ávita Care's registration processes were completed on May 25th. However, the Brazilian pharmaceutical company's registration was approved the following day, while Ávita Care's was approved more than a month later.

Anvisa confirmed to NeoFeed that there was a change in evaluation midway through the process between the registration request and the approval of the pen.

"Given the regulatory change that now requires a certificate of good manufacturing practices for APIs (August 1, 2023), the Attorney General's Office was consulted regarding the need for this requirement in this specific case, and it was clarified that the signing of a commitment agreement would resolve this issue," the agency says.

The agency has not yet disclosed why it did not sign the agreement with Ávita Care earlier, in time for the registration to be approved shortly after EMS's.

"The exemption from certification, provided for in the applicable regulation at the time, does not preclude the agency's authority to verify the quality of the input when necessary," the note adds.

Change of direction

The process at Anvisa (Brazilian Health Regulatory Agency) that resulted in the approval of Ozowy was initiated by the pharmaceutical company Eurofarma, which initially intended to launch its own slimming pen. However, in October of last year, it changed its plans, announcing the sale of Poviztra, a semaglutide that is also produced by Novo Nordisk.

With this, Eurofarma relinquished the technical dossier, which was passed on to Ávita Care to take over the regulatory process – a practice accepted in the market. Since the company does not sell products, Adalvo partnered with Sandoz to bring the pen to Brazilian pharmacies.

The product that will arrive in Brazil will be manufactured at Adalvo's Canadian plant, with the active pharmaceutical ingredient (API) imported from a partner factory in Shanghai.

But the Adalvo name will not appear on the product. The pen box will feature the Ávita Care and Sandoz logos.

In general, Anvisa has tightened regulations in the sector to inhibit the increased entry of imported pens, mainly from Paraguay, which do not have approval from the Brazilian agency.

For Pimenta, these new rules are important to ensure a safer environment. "Anvisa has a genuine concern for LPG-1, to ensure that consumers receive something with a traceable origin, especially regarding products from Paraguay. This is important," says the businesswoman.

A recent report from Itaú BBA shows that the market for slimming pens (including semaglutide, liraglutide, and tirrizepatide) is expected to reach R$ 18 billion in 2026.

However, the informal market, with products that arrive illegally, is even larger, according to the bank's projection, at R$ 19 billion. This means that, in total, adding legal and smuggled pens, the market should close the year with R$ 37 billion.

Today, the market already has five brands of semaglutide (four from Novo Nordisk and one from EMS). With Anvisa's approval, the trend is that at least four more will reach the market by the end of 2026, since one of the brands approved by Hypera Pharma is not expected to be manufactured initially.

No price has been officially published yet, but the expectation is that all the new pens will not reach the market at a price higher than that of the EMS pen, which currently costs around R$ 430 on a three-month purchase plan.

A report released Wednesday by BTG Pactual shows that, from now on, the trend is towards lower prices and an increase in the category's revenue for retail chains in the sector. The question now is regarding the margins of these cheaper products, which are lower than those of Novo Nordisk.

"Despite significantly lower initial gross margins than those of traditional pharmaceutical products (around 18% during the launch phase), we expect that the progressive increase in the scale of purchases, competition among suppliers, and improved procurement conditions will drive the convergence of the gross margin to around 25% by the end of 2026 and above 30% in the medium term," the bank explains in the document.