Brazil approves first synthetic semaglutide alternative to Ozempic

Brazil's health regulator gave the green light this week to Ozivy, a new semaglutida injection pen made by the pharmaceutical company EMS. The approval marks a significant shift in the country's weight-loss and diabetes medication landscape—it is the first synthetic version of semaglutida to reach the Brazilian market now that the original patent has expired. The drug is designed to treat adults with type 2 diabetes that isn't adequately controlled through diet and exercise alone, and it comes as a weekly injection, just like its better-known predecessor, Ozempic.

What makes Ozivy technically distinct is its origin. The original semaglutida medications sold in Brazil—Ozempic and Wegovy from Novo Nordisk, plus the identical versions Extensior and Poviztra made locally by Eurofarma—are all biologic drugs, meaning they are derived from living systems or created through genetic manipulation. Ozivy, by contrast, is synthesized through chemical processes, which produces smaller, more stable molecules that can be reproduced identically. This distinction matters for regulators: Brazil's rules do not permit true generics of biologic drugs, so Ozivy occupies a middle category—not a generic in the legal sense, but a synthetic alternative. The Anvisa, Brazil's health agency, notes that it is among the first regulatory bodies in the world to approve this type of product.

The path to approval took time. EMS submitted its application in 2023 and navigated the standard process of proving efficacy, safety, and quality. The agency prioritized review of domestically produced weight-loss pens, a deliberate choice that reflects both national industrial policy and the growing demand for these medications. Five more synthetic semaglutida variants and one biologic version are still under review. The company invested more than 1.2 billion reais to build the peptide manufacturing platform at its facility in Hortolândia, São Paulo, which has the capacity to produce up to 40 million pens annually.

Price is the story that matters most to patients. EMS has pledged that Ozivy will cost roughly 30 percent less than Ozempic, though the company has not disclosed exact figures. The drug still must clear one more regulatory hurdle—the pricing board that sets maximum prices in Brazil—before it can reach pharmacies, a process expected to take days. Once approved, EMS says the medication will be available within a month. The promise of lower costs addresses a real problem: the underground market for semaglutida has expanded as people seek alternatives to expensive branded versions, and improper manipulation of these medications outside official channels has become a concern.

The storage requirements differ slightly from Ozempic. Ozivy must be refrigerated at temperatures between 2 and 8 degrees Celsius both before and after a patient begins using it. Ozempic, by contrast, only requires refrigeration before use and can tolerate temperatures up to 30 degrees Celsius for up to six weeks once treatment starts. In clinical trials, semaglutida at a 2.4 milligram dose produced weight loss of approximately 17.4 percent over 68 weeks—roughly sixteen months—in people who completed the study.

The broader context is important. The original semaglutida patent expired in Brazil in March, opening the door for competitors to develop and seek approval for their own versions. Patents typically protect innovative drugs for up to twenty years, giving the developer exclusive commercial rights during that window. Once that protection ends, other manufacturers can submit their own formulations. In Brazil's generic drug market, competitors typically price their products 59 to 60 percent below the original, though similar drugs—those not quite generics but close alternatives—tend to be about 15 percent cheaper.

Paulo Miranda, a former president of Brazil's endocrinology society, welcomed the approval as a step toward broader access. He emphasized that the real test will be whether increased competition actually drives prices down and whether the government eventually decides to add these medications to the public health system. In 2025, the health ministry rejected incorporating semaglutida into the public system, citing a projected cost of more than 8 billion reais—nearly double the annual budget of the Popular Pharmacy program. Lower prices from new competitors could change that calculation, though no decision has been made. For now, Ozivy represents a crack in the wall of expensive weight-loss medications, and what comes through that crack will depend on how aggressively EMS and other manufacturers compete on price.