en.Wedoany.com Reported - Ávita Care is accelerating the submission of final supplementary materials to Brazil's National Health Surveillance Agency (Anvisa) to secure registration approval for its semaglutide weight-loss pen within June. The company is advancing this product in the Brazilian market on behalf of European pharmaceutical manufacturer Adalvo (Malta).

Headquartered in Vinhedo, São Paulo state, Ávita Care is part of the Soluto Group. As the Anvisa registration holder, it is responsible for legal representation, import, warehousing, distribution, and pharmacovigilance of Adalvo's products. Commercialization of this weight-loss pen in Brazil will be transferred to Swiss pharmaceutical company Sandoz. Since February, Isabella Wanderley has served as president of Sandoz Brazil, having previously led Novo Nordisk's Brazilian subsidiary from August 2021 to September 2025.

Ávita Care's partnership model with Sandoz mirrors the agreement Novo Nordisk reached with Eurofarma late last year. Novo Nordisk and Eurofarma launched the Poviztra weight-loss pen, also based on semaglutide, in October last year. The product aims to offer a cheaper GLP-1 analog alternative to Ozempic and Wegovy, mitigating the impact of new competitors entering the market after patent expirations. Novo Nordisk's patents for Ozempic and Wegovy expired at the end of March.

Through its partnership with Sandoz, Ávita plans to ensure a distribution scale comparable to EMS. EMS previously stated it planned to produce 1.2 million units in the first year, with an initial distribution of 350,000 weight-loss pens. A senior executive familiar with the matter said the company is prepared to begin pharmacy distribution immediately upon registration, aiming to enter the Brazilian market competitively.

On May 25, Anvisa changed Ávita Care's internal registration status to "analysis complete." However, technical staff at the regulatory agency requested further clarification on Good Manufacturing Practices at Adalvo's production sites. Adalvo plans to manufacture semaglutide at facilities in Canada and China. Last year, Anvisa announced it would prioritize semaglutide registration applications, approving only two products every six months under this model.

EMS's Ozivy weight-loss pen received registration approval on May 26, becoming the first semaglutide drug manufactured in Brazil. The product is confirmed to be available in pharmacies starting June 15, priced at 452 reais per single-pen box. For patients opting for a three-month course, a box of two pens (1mg each) costs 863.23 reais. EMS Vice President Marcus Sanchez stated that this pricing will ensure broader access to these products for Brazilian patients.

Ávita Care is striving to avoid semaglutide repeating the trajectory of liraglutide. After liraglutide's patent expired in Brazil in November 2024, EMS received Anvisa approval and launched the Olire (for obesity) and Lirux (for type 2 diabetes) weight-loss pens in August last year, becoming the only company producing liraglutide in Brazil. Before approving EMS's semaglutide, Anvisa rejected Indian pharmaceutical company Dr. Reddy's application for the Embeltah weight-loss pen due to a lack of evidence on efficacy, safety, and quality.

Pharmaceutical companies are competing for a market projected to exceed 15 billion reais in 2026 (including all weight-loss pens approved in Brazil). Last year, retail chains generated 10 billion reais in revenue from these products. Global trends show the worldwide GLP-1 market reached $63 billion last year, with expectations to surpass $73 billion by 2026. The drug's share of prescriptions at major U.S. pharmacy chains has risen from less than 1% five years ago to 8%.

Ávita Care did not respond to interview requests. Sandoz stated it does not comment on potential or possible partnerships. Anvisa indicated that there are currently 13 synthetic semaglutide registration applications and 4 biological semaglutide registration applications, and it cannot provide a timeline in advance.

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