Sandoz, the global leader in affordable medicines, confirms that the Agência Nacional de Vigilância Sanitária (ANVISA) has granted marketing authorisation for Owozy® (semaglutide), which Sandoz will commercialise in Brazil in partnership with Adalvo.
Owozy was developed by Adalvo and is approved for the treatment of type-2 diabetes. It will be available in Brazil in a pre-filled delivery system (multi-dose disposable pen), designed to facilitate use by both patients and healthcare professionals. It is among the first new semaglutide treatment options approved in Brazil, in a market worth an estimated USD 1.8 billion1, and paves the way for an expected launch in the second half of 2026.
Richard Saynor, Sandoz Chief Executive Officer, says: “This first-wave regulatory approval for a new semaglutide treatment option in Brazil marks meaningful progress in ensuring access to a vital medicine. Through our partnership with Adalvo and commercial rights in this key market, we are one step closer to bringing a high-quality treatment option to patients with type-2 diabetes.
“This will support the sustainability of local healthcare systems and further advance our Purpose of pioneering access for patients. It represents a key early step towards our goal of making the next 10 years our ‘golden decade’, as medicines worth more than USD 650 billion lose exclusivity.”
It is estimated that more than 16.5 million Brazilians live with diabetes, including type-2 diabetes, placing the country among those with the highest prevalence worldwide. In addition, around one in three people with diabetes are still undiagnosed, representing more than five million individuals in Brazil. Even diagnosed patients face barriers to adequate treatment, reinforcing the need to expand the availability of effective and accessible therapies across the country.
Overall, this regulatory approval contributes to the continued Sandoz leadership in affordable medicines. It underscores the Company’s commitment to help millions of patients access biosimilar and generic medicines sustainably and affordably through a global portfolio of more than 1,300 medicines, supported by an industry-leading pipeline of over 400 additional assets.
The approval has no impact on the Company’s financial guidance for 2026. The anticipated launch in the second half of the year is in line with Sandoz expectations, and the Company foresees no material contribution this year from any potential launch of generic semaglutide.
