Sandoz confirms regulatory approval for new semaglutide treatment option in Brazil, paving way to expand patient access

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules
MEDIA RELEASE
 

• Sandoz has commercial rights in USD 1.8 billion GLP-1 local market; positioned for launch in second half of 2026

• More than 16.5 million Brazilians live with diabetes; disease remains key public health challenge in Brazil

• Potential to expand patient access to high-quality new semaglutide treatment option and support local healthcare systems

Basel, 29 July 2026 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, today 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 worldwide². In addition, around one in three people with diabetes are still undiagnosed, representing more than five million individuals in Brazil³. Even diagnosed patients face barriers to adequate treatment, reinforcing the need to expand the availability of effective and accessible therapies across the country⁴.
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.
DISCLAIMER
This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law.
REFERENCES
¹ Data on file. Based on full year 2025 IQVIA Analytics Link data
²International Diabetes Federation. Brazil: Diabetes country report 2000 – 2050. Available at: Diabetes Data in Brazil | IDF Diabetes Atlas [Last accessed: July 2026]
³ International Diabetes Federation. Brazil: Diabetes country report 2000 – 2050. Available at: Diabetes Data in Brazil | IDF Diabetes Atlas [Last accessed: July 2026]
⁴ International Diabetes Federation. Brazil: Diabetes country report 2000 – 2050. Available at: Diabetes Data in Brazil | IDF Diabetes Atlas [Last accessed: July 2026]
ABOUT SANDOZ
Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 colleagues of 100 nationalities work together to ensure over one billion patients are reached by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 medicines addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. In 2026, Sandoz celebrates 20 years of pioneering biosimilars, 80 years of antibiotics manufacturing and 140 years of heritage. In 2025, Sandoz recorded net sales of USD 11.1 billion.
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