By Brazil Stock Guide – Hypera Pharma (B3: HYPE3) entered Brazil’s rapidly expanding GLP-1 market on Wednesday after securing regulatory approval for Semavy, its injectable semaglutide medicine, becoming the latest domestic competitor to Novo Nordisk following EMS’s launch of Ozivy, the country’s first commercially available synthetic semaglutide pen.
The product will be marketed under Hypera’s Mantecorp brand and is expected to reach Brazilian pharmacies within two months, after the company completes the operational and commercial stages of the launch.
Semavy was one of five injectable semaglutide medicines approved on Wednesday by Brazil’s health regulator, Anvisa, marking the largest simultaneous batch of GLP-1 agonist registrations ever granted by the agency.
The other products approved were Owozy, registered by Ávita Care; Seemasun, by Sun Farmacêutica do Brasil; Zempneo, by Brainfarma; and Orsema, by Ranbaxy Farmacêutica. With both Semavy and Zempneo approved, Hypera-related companies accounted for two of the five new registrations.
According to Anvisa, all five medicines contain synthetically produced semaglutide and were registered through comparison with Novo Nordisk’s Ozempic. They were approved for adults with inadequately controlled type 2 diabetes as an adjunct to diet and exercise, either as monotherapy when metformin is inappropriate because of intolerance or contraindications, or in combination with other diabetes medicines. The approvals do not currently include obesity treatment.
The approvals represent another step in Brazil’s effort to increase the supply of GLP-1 medicines following the expiration of Ozempic’s patent earlier this year. EMS became the first company to commercialize a synthetic semaglutide pen in Brazil with the launch of Ozivy in June, and the latest approvals are expected to intensify competition in one of the pharmaceutical industry’s fastest-growing segments.
For Hypera, the launch opens a new growth avenue in a market that generated R$15.6 billion in consumer purchases over the 12 months through May 2026, up 111% from a year earlier, according to IQVIA data cited by the company.
“The medicine will help expand the domestic supply of semaglutide and make this type of treatment increasingly accessible and available to the Brazilian population,” Hypera Chief Executive Breno Oliveira said in a statement.
“We want to ensure that more Brazilians can start and, above all, remain on treatment with a high-quality product at a fair price,” he added.
Hypera did not disclose Semavy’s expected retail price, sales targets or projected market share. The company also did not provide details on initial production volumes or supply capacity.
Anvisa said the approvals are part of an accelerated review program launched in 2025 at the request of Brazil’s Health Ministry to expand the availability of semaglutide and liraglutide medicines. Of the 24 synthetic and biologic products included in the initiative, 11 have completed the review process and six have now been approved.
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