New Brazilian slimming pen: how does synthetic semaglutide work?

Anvisa (National Health Surveillance Agency) announced today the release of the EMS drug Ozivy, made with synthetic semaglutide and considered an analogue of Ozempic (drug from Novo Nordisk).

The new Brazilian weight loss pen does not yet have a defined price or launch date. But the vice-president of the pharmaceutical company believes that pricing should be 30% lower than the main options available.

What is synthetic semaglutide and how does the new pen work?
Semaglutide is a substance analogous to two hormones in our intestine: GLP-1 and GIP. When ingested, it increases the feeling of satiety by slowing stomach emptying. As a result, the person eats less and ends up losing weight. Other mechanisms of these hormones help with weight loss as well, such as reducing a person's thoughts about food (a phenomenon known as "food noise").

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The difference between Ozivy and Ozempic is that the semaglutide in EMS pens is synthetic. According to endocrinologist Andressa Heimbecher, the semaglutide used in Ozempic and Wegovy is created by the biological process of Saccharomyces yeast (something similar to beer production).

The synthetic molecule is made in the laboratory, replicating the structure and composition of the original molecule. However, there is no point in them just being the same, studies are needed to show that they act in the same way, called bioequivalence. "It is necessary to show that that synthetic molecule has the same behavior in the body as the biological molecule: both the way it is absorbed, how it is transported in the blood, how it has adverse effects, how it works. So, in clinical practice, it is about knowing whether it delivers the same effects that we already know in clinical practice as the original molecule", summarizes Heimbecher.

Therefore, the approval of this new medication by Anvisa is based on the bioequivalence studies shown by EMS. So much so that the pen is not being considered a generic, but rather a new medicine, technically defined as a synthetic analogue of a biological product.

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Source: CNN