Brazil is among the first countries to authorize this type of product
Ozivy is Brazil's first domestically-approved synthetic GLP-1 agonist, developed by EMS after Ozempic's patent expiration in March 2024. Unlike the reference drug, Ozivy requires refrigeration (2-8°C) and represents a technical achievement as synthetic alternatives to biologics are complex regulatory challenges globally.
- Ozivy is the first synthetic semaglutida approved in Brazil, developed by EMS after Ozempic's patent expired in March 2026
- Unlike Ozempic, Ozivy requires refrigeration at 2-8°C before and after use, versus room temperature storage for the reference drug
- Five other synthetic and one biologic semaglutida formulation remain under Anvisa review
- Commercialization awaits price approval from CMED; eventual public health system inclusion requires additional Conitec and Health Ministry review
Brazil's health regulator Anvisa approved Ozivy, the first synthetic semaglutide injection similar to Ozempic, marking a regulatory milestone. The drug still awaits price approval before pharmacy availability.
Brazil's health regulator gave the green light this week to Ozivy, a domestically produced weight-loss injection that marks a significant shift in how the country will access one of the world's most sought-after diabetes and obesity medications. The Anvisa approval, announced Tuesday, clears the way for EMS Pharma to bring the first synthetic version of semaglutida to Brazilian pharmacies—a drug class that has become synonymous with the injectable pens people line up for and sometimes travel abroad to obtain.
The story begins with expiration. When Novo Nordisk's patent on Ozempic expired in March, it opened a window for competitors to develop their own versions. EMS filed its application back in 2023, and the drug has now passed Anvisa's rigorous technical review of safety, efficacy, and manufacturing quality. What makes Ozivy distinct is not just that it's Brazilian-made, but how it was made: rather than using biological material grown in living cells like the original Ozempic, Ozivy is synthesized through chemical processes. This distinction matters because it allows for smaller, more stable molecules—though it also introduces new regulatory complexities that few agencies worldwide have yet tackled.
The medication itself works the same way. It's prescribed for adults with type 2 diabetes that diet and exercise alone haven't controlled, either on its own or combined with other diabetes drugs. It comes as a weekly injection in a prefilled pen, just like its reference drug. But there's a practical difference that patients will notice: while Ozempic can sit at room temperature up to 30 degrees Celsius for six weeks after opening, Ozivy must stay refrigerated between 2 and 8 degrees Celsius both before and after use begins. The drug comes in four different package configurations, ranging from single pens with 1.5 milliliters of solution to dual pens with 3 milliliters, each bundled with varying numbers of needles.
The approval itself represents a technical achievement that Anvisa emphasizes has eluded most regulatory agencies globally. Synthetic semaglutida sits in an unusual category—it borrows characteristics from both chemical drugs and biological ones, which means it carries risks of triggering immune responses and forming protein clumps that regulators must carefully monitor. Brazil is among the first countries to authorize this type of product, a fact the agency highlighted in its announcement. The drug is not classified as a generic, because Brazilian law doesn't recognize generics of biological medications. Instead, Ozivy is labeled a "new medication," a synthetic analog of an existing biologic.
But approval is not the same as availability. Before Ozivy reaches pharmacy shelves, the price-setting authority CMED must establish a maximum price, and EMS will decide when to actually launch. The company has not announced a timeline. If the government eventually wants to offer it through the public health system, another layer of review awaits: the national commission that evaluates new health technologies would need to assess it, and the Health Ministry would need to sign off. Meanwhile, five other synthetic semaglutida formulations and one biologic version remain under Anvisa review, suggesting the market for these injections in Brazil is about to become considerably more crowded.
Citações Notáveis
These products present high complexity, combining characteristics of both synthetic and biological medications, including risks of immune response and protein aggregation— Anvisa statement on synthetic semaglutida regulatory challenges
A Conversa do Hearth Outra perspectiva sobre a história
Why does it matter that this is synthetic rather than biological? Isn't the active ingredient the same?
The active ingredient does the same job in your body, yes. But synthetic means it was built molecule by molecule in a lab rather than grown in cells. That lets you make smaller, more stable versions. The tradeoff is complexity—regulators have to watch for immune reactions and protein clumping that don't happen with the biological version.
So Ozivy is cheaper to make?
Potentially, yes. That's partly why the patent expiration mattered so much. But we won't know the actual price until CMED sets it. EMS could price it aggressively to grab market share, or conservatively to protect margins. That decision hasn't been made public.
The refrigeration requirement seems like a real inconvenience.
It is. Ozempic's stability at room temperature for six weeks is a genuine advantage for patients who travel or live in hot climates. Ozivy users will need to plan around that. Whether that becomes a dealbreaker depends on how much cheaper it is and how the market responds.
Why is Brazil approving this before most other countries?
Anvisa moved fast, partly because the patent expiration created urgency and partly because they had a clear regulatory pathway for it. Most agencies are still figuring out how to evaluate synthetic biologics. Brazil got ahead of the curve.
What happens if this works well and becomes popular?
Then five more synthetic versions are waiting in the queue behind it. The market could fragment quickly. Prices might fall. Access could improve. But it also means EMS has a narrow window to establish itself before competition arrives.