The expiration of semaglutide’s patent protection in Brazil in March 2026 opened the market to new products and accelerated activity among pharmaceutical companies developing medicines based on the active ingredient. Since May, the Brazilian Health Regulatory Agency (Anvisa) has approved more synthetic semaglutide products.
According to a report published by VEJA, more than ten injectable semaglutide medicines have received Anvisa approval, including generic and similar medicines. The movement is expanding competition in a segment previously dominated by biological reference products.
New trademarks enter the market
On July 29, Anvisa approved five new synthetic semaglutide products: Owozy, Seemasun, Zempneo, Semavy and Orsema. They joined Ozivy, developed by EMS and registered in May as the first synthetic semaglutide product approved as an analogue of the biological reference product.
The trademarks identified by VEJA also include products approved later under different regulatory categories:
-
Ozivy (EMS): the first synthetic semaglutide version registered in Brazil;
-
Owozy (Ávita Care/Biolab/Sandoz): approved by Anvisa in July;
-
Seemasun (Sun Farmacêutica do Brasil): approved in July;
-
Zempneo (Brainfarma): approved in July;
-
Semavy (Mantecorp/Hypera Pharma): approved in July;
-
Orsema (Ranbaxy Farmacêutica): approved in July;
-
Semaclique (Germed/EMS): a similar version of Ozivy, also approved as a generic;
-
Yluméc (EMS): approved as a similar medicine in August.
The approvals are part of a broader regulatory review of GLP-1 receptor agonists. According to Anvisa, 68% of applications for injectable medicines intended to treat obesity and diabetes are for synthetic products.
Synthetic and biological semaglutide: what is the difference?
The new products are not simply copies of the biological reference medicine.
Recently approved products use chemically synthesized semaglutide, while medicines such as Ozempic and Wegovy use biologically derived semaglutide. Anvisa classifies Ozivy, for example, as a new medicine and synthetic analogue of a biological product, rather than a generic version of Ozempic.
The distinction relates to how the active ingredient is produced:
- Biological semaglutide: produced through biotechnological processes;
- Synthetic semaglutide: produced through chemical synthesis.
According to Anvisa, evaluating synthetic semaglutide analogues presents technical challenges because these products combine characteristics associated with both synthetic and biological medicines.
Generics and similar medicines enter the market
The market opening also involves different regulatory categories.
According to VEJA, Ozivy and Semaclique have been authorized for sale as generic medicines, while other products have been registered as similar medicines.
For generics, Brazilian regulation requires the medicine to have the same active ingredient and efficacy as the reference product, without using a proprietary brand name. Similar medicines, by contrast, are marketed under their own commercial names and registered against a reference product.
The diversification of regulatory categories increases the number of companies able to compete in the segment and creates a different market structure from the one that existed during the patent protection period.
Patent expiration accelerates new applications
The expiration of semaglutide’s patent on March 20, 2026, was one factor behind the increase in regulatory applications.
Anvisa reported that, since August 2025, it has prioritized the review of medicines containing semaglutide and liraglutide following a request from Brazil’s Ministry of Health and concerns about domestic supply, within the framework of the Health Economic-Industrial Complex.
Of the 24 synthetic and biological medicines included in the priority review program, 11 had completed the assessment, resulting in six approvals as of July 2026.
