Brazil approves two more synthetic semaglutide pens as interchangeable with Ozivy
Two more lower-cost semaglutide pens are cleared in Brazil, the region's largest GLP-1 market, giving patients there more post-patent options than anywhere else [1].
Brazil's health regulator ANVISA has authorized two additional synthetic semaglutide pens — an EMS generic and Germed's Semaclique — as interchangeable with Ozivy, the first synthetic semaglutide pen it cleared in May 2026 [1]. With those decisions, at least seven semaglutide products have been registered in Brazil since the molecule's patent expired there in March 2026 [1].
Several basics about the two new products have not been disclosed, including their prices, the dose strengths covered and the standards ANVISA used to judge them swappable for Ozivy [1]. What the May clearance of Ozivy did establish, according to a market analysis of South American GLP-1 agonists, was a regulated channel for domestic competition and added price pressure on branded injectable semaglutide [1].
Brazil is where that pressure will be measured first. The country produced 59.82% of South American GLP-1 revenue in 2025, the analysis found [1]. Regional revenue was put at USD 1.62 billion for 2025, USD 1.73 billion for 2026 and USD 2.58 billion by 2031, an 8.34% annual growth rate [1]. Semaglutide — sold as Ozempic, Wegovy and Rybelsus — accounted for 51.35% of regional GLP-1 revenue in 2025, injectable pens made up 87.42% of the market, and type-2 diabetes represented 78.13% of revenue, with obesity and weight management the fastest-growing use at a 10.17% yearly pace through 2031 [1]. Tirzepatide, sold as Mounjaro and Zepbound, is a different molecule, forecast to grow 9.22% a year in the region and described in the analysis as insulated from the Brazilian semaglutide price cycle [1].
Generic manufacturers are treating Brazil as a proving ground. Sandoz received approval for its generic semaglutide there in July and expects a Canada launch this year for patients with diabetes [2]. The company's sales targets for 2025 through 2035 exclude any contribution from generic GLP-1 medicines [2]. Chief financial officer Remco Steenbergen declined to put a number on the opportunity, saying forecasts remain highly uncertain, but described it as worth "billions" and said the market could expand to between two and seven times its current size once cheaper copies reach patients [2].
Why it matters for patients
Brazil is the first sizable market where multiple approved post-patent semaglutide pens compete with the brand at the same time, which is why its pricing is being watched [1][2]. Lower prices there do not automatically translate into lower prices elsewhere. In South America, availability of innovative cardiometabolic medicines trails approval by 22 to 43 months, with the longest gaps in Chile, Brazil and Panama, according to the analysis [1]. Chile leaves GLP-1 medicines out of its public system, Colombia requires prior authorization for liraglutide, and Argentina restricts some reimbursement to patients with documented cardiovascular events [1].
Cost is identified as the biggest obstacle. Branded tirzepatide and high-dose semaglutide can exceed the budgets of many middle-income households, and the analysis says expense can lead people to delay treatment or stop it [1]. Safety runs alongside price: counterfeit, compounded and irregularly imported products are listed as a risk in Brazil and Argentina, and ANVISA has cited manufacturing noncompliance and sales without prescriptions [1].
In the United States, no generic semaglutide has been approved or launched, and none has been announced [2]. Sandoz says it continues to talk with the Trump administration and would like to invest in U.S. production [2].
What happens next
The order of events in Brazil so far: the semaglutide patent expired in March 2026, Ozivy was cleared that May, Sandoz's generic was approved in July, and the EMS and Germed pens followed [1][2]. ANVISA also approved a multidose Mounjaro pen in March 2026 that packs six concentration formats into one device [1]. Novo Nordisk announced an 8 billion DKK (about USD 1.26 billion) production investment in Montes Claros, Brazil, in 2025, and a public-system pilot covering 1,000 patients at three health units in 2026 [1]. Sandoz has said it expects to launch its generic semaglutide in Canada this year [2].
Sources
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