Sandoz said Brazil’s health regulator has granted marketing authorization for Owozy, a semaglutide treatment for type 2 diabetes, clearing the way for a launch in the second half of 2026.
The company said it will commercialize the product in Brazil in partnership with Adalvo. Owozy will be offered in a pre-filled delivery system, a multi-dose disposable pen designed to be easier for patients and healthcare professionals to use. Sandoz said the approval gives it commercial rights in Brazil’s estimated $1.8 billion GLP-1 market and places the product among the first new semaglutide treatment options approved in the country.
Brazil has more than 16.5 million people living with diabetes, including type 2 diabetes, making the disease a major public health challenge. Sandoz said about one in three people with diabetes in Brazil remain undiagnosed, leaving more than five million people unaware of their condition. Even for diagnosed patients, barriers to treatment persist, underscoring the need for broader access to effective therapies.
Chief Executive Officer Richard Saynor said the approval represents meaningful progress in expanding access to a vital medicine and fits with Sandoz’s purpose of pioneering access for patients. He said the company’s partnership with Adalvo and its commercial rights in the market should help bring a high-quality treatment option to patients while also supporting the sustainability of local healthcare systems.
Sandoz said the approval does not affect its 2026 financial guidance. The company also said it expects no material contribution this year from any potential launch of generic semaglutide. It framed the Brazilian approval as an early step in its broader strategy as more medicines lose exclusivity over the next decade.
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