A massive backlog of people who wanted it but couldn't get it
Com a expiração da patente do Ozempic em março, a farmacêutica brasileira EMS obteve aprovação da Anvisa para o Ozivy, sua versão doméstica da semaglutida — um medicamento que, nascido para tratar o diabetes tipo 2, tornou-se símbolo de uma era em que a fronteira entre saúde e desejo estético se dissolve. A empresa promete preços 30% abaixo dos concorrentes e projeta 1,2 milhão de doses no primeiro ano, mas data de lançamento e valor final ainda não existem. É o momento em que uma vitória regulatória ainda não se traduz em acesso real — e em que a promessa de democratização de um tratamento aguarda o teste do mercado.
- A demanda reprimida por semaglutida no Brasil é tão vasta que a própria EMS admite não conseguir dimensioná-la — milhões de pessoas esperam por um acesso que o Ozempic original nunca foi capaz de suprir.
- A aprovação da Anvisa é concreta, mas o lançamento permanece suspenso: sem preço definido e sem data, o Ozivy existe por ora apenas no papel regulatório.
- A empresa tenta equilibrar acessibilidade e margem de lucro, prometendo 30% de redução em relação aos concorrentes, mas ainda trabalhando nos números que tornarão essa promessa real.
- A estratégia inicial foca em pacientes diabéticos com prescrição médica — um recorte cauteloso que, diante de projeções de R$ 500 milhões em receita no primeiro ano, mal disfarça ambições muito mais amplas.
- O medicamento chega em quatro formulações escalonadas, criando múltiplos pontos de entrada no mercado e sinalizando que o público-alvo vai muito além das clínicas de endocrinologia.
Na manhã de terça-feira, a EMS anunciou que a Anvisa havia aprovado o Ozivy, sua versão nacional da semaglutida — o mesmo princípio ativo do Ozempic — abrindo caminho para um concorrente doméstico num mercado que cresceu muito além de suas origens médicas. A aprovação chegou meses após a expiração da patente do medicamento original, em março, desbloqueando legalmente a entrada de competidores.
Mas entre o aval regulatório e a chegada às farmácias há um intervalo ainda sem forma. Marcus Sanchez, vice-presidente da empresa, reconheceu na coletiva de imprensa que preço e data de lançamento seguem indefinidos. A promessa é de um valor 30% inferior ao dos líderes de mercado — mas os cálculos ainda estão sendo feitos, e a empresa enquadra a demora como compromisso com a acessibilidade, não como hesitação.
O Ozivy pertence à classe dos agonistas GLP-1, drogas que regulam glicemia e apetite. Sua indicação original é o diabetes tipo 2, doença que afeta milhões de brasileiros. Mas a semaglutida há muito transbordou esse limite: tornou-se objeto de desejo para quem busca perda de peso, com ou sem diagnóstico. Sanchez admitiu que existe uma demanda reprimida enorme — tão grande que a empresa sequer consegue estimá-la.
A estratégia de entrada é conservadora: o medicamento será vendido inicialmente apenas com prescrição médica, direcionado a pacientes diabéticos. Ainda assim, as projeções — 1,2 milhão de doses e R$ 500 milhões em receita no primeiro ano — revelam ambições que ultrapassam em muito o consultório do endocrinologista. O produto virá em quatro formulações, de 0,25 mg a 1 mg, permitindo escalonamento de dose e múltiplos pontos de acesso ao mercado.
A batalha regulatória foi vencida. A comercial ainda não começou.
On Tuesday morning, EMS announced that Brazilian regulators had cleared its homegrown version of the weight-loss drug that has dominated conversations about diabetes treatment and body composition for the past two years. The medication, called Ozivy, is a synthetic semaglutide—the same active ingredient in Ozempic—and it arrived at a moment when the original drug's patent had already expired, opening the door for competitors to enter a market that had grown far beyond its original medical purpose.
Yet the company offered no timeline for when patients could actually buy it, and no price tag either. During a press conference on the morning of the approval, Marcus Sanchez, the company's vice president, acknowledged the gap between regulatory clearance and real-world availability. The drug would be cheaper than what currently dominates pharmacy shelves, he promised—roughly 30 percent below the leading options on the market—but the final number remained unsigned. The company was still working through the math of how to make the medicine accessible without sacrificing margin, he said, framing the delay as a commitment to affordability rather than a stumble.
Ozivy belongs to a class of medications called GLP-1 agonists, drugs that regulate blood sugar and appetite. The original indication was type 2 diabetes, a serious metabolic disease affecting millions of Brazilians. But the drug had become something else in the public imagination: a tool for weight loss, a shortcut to thinness, something people wanted not because they were sick but because they wanted to be thinner. The demand was enormous and largely unmet. Sanchez acknowledged this directly. There was, he said, a massive backlog of people who wanted semaglutida but couldn't get it—a repressed demand so large the company couldn't even estimate its size. The market was hungry, and EMS was positioning itself to feed it.
The company's initial strategy was cautious. At launch, Ozivy would be marketed primarily to diabetic patients, available only by prescription, only through physicians. This was the legal and medical framework, the guardrail. But everyone in the room understood that diabetics were only part of the story. The company projected selling 1.2 million doses in the first year, generating 500 million reais in revenue. Those numbers suggested ambitions that extended well beyond the diabetes clinic.
The medication would come in four formulations: pens containing 0.25 milligrams, 0.5 milligrams, 1 milligram, or two pens of 1 milligram each. This tiered approach allowed for dose escalation, the standard protocol for GLP-1 drugs, where patients start low and gradually increase to find their therapeutic sweet spot. It also created multiple price points, multiple entry doors into the market.
What remained unresolved was the central question: when would this actually reach people, and at what cost? Sanchez had committed to transparency and accessibility, but those were promises about a future that had no date. The approval was real. The manufacturing capacity was presumably ready. But the moment when a Brazilian diabetic or a Brazilian person seeking weight loss could walk into a pharmacy and buy Ozivy remained suspended in an undefined tomorrow. The company had won the regulatory battle. The commercial one had not yet begun.
Notable Quotes
We're working to make the price accessible to doctors and patients, below what's currently on the market. The final price isn't set yet, but we're focused on affordability.— Marcus Sanchez, EMS vice president
There's a huge repressed demand we can't even estimate. We need to create options for doctors and patients.— Marcus Sanchez, EMS vice president
The Hearth Conversation Another angle on the story
Why did it take until now for a Brazilian company to make this drug, given that the patent expired in March?
The patent expiration opened the door, but manufacturing a GLP-1 agonist isn't simple. You need the right facilities, the right expertise, regulatory approval. EMS had to move fast, but they still had to move right. The approval came through in May—that's only two months after the patent fell. That's actually quite quick.
So why no price yet? They've had months to figure that out.
Pricing in Brazil is complicated. You're balancing what the market will bear against what the government might reimburse, against what patients can actually afford. If you price too high, you look greedy when you're supposed to be the affordable option. If you price too low, you can't sustain production. They're probably still negotiating with health systems and insurance companies.
The company says it's targeting diabetics first. Do they actually believe that, or is that just legal cover?
Both, probably. Legally and ethically, diabetes is the approved indication. That's where the prescription requirement makes sense. But the vice president basically admitted the real demand is much larger and harder to measure. They know what's coming. They're just being careful about how they walk into it.
1.2 million doses in year one seems like a lot. Is that realistic?
It depends on what you mean by realistic. If you're talking about the total addressable market—everyone in Brazil who wants semaglutida—then 1.2 million is probably conservative. But actually manufacturing and distributing that many doses, getting them prescribed, getting them paid for? That's a different question. It's an ambitious target that signals confidence, but also uncertainty about what the real demand curve looks like.
What happens if they can't deliver on the price promise?
Then they lose the entire narrative advantage they've built. They're the domestic alternative, the affordable option. If they launch at prices close to Ozempic, they become just another competitor with less brand recognition. The whole point of this story is that Brazilians finally have a choice. If that choice doesn't actually cost less, the story collapses.