Basel, Switzerland
Sandoz
Swiss generic and biosimilar medicines company. In GLP-1s it has a marketing authorisation for a generic semaglutide (a version of Ozempic) in Canada, holds commercial rights to a semaglutide product approved in Brazil that was developed by Adalvo, and has US FDA applications under review for an in-house generic tirzepatide. Its tirzepatide applications are under FDA review and are not approved. Details below are as Sandoz states them in its own media releases.
Last verified 2026-09-29 · how we verify
Company website- Canada: generic semaglutide (September 2026)
- On 18 September 2026 Sandoz announced that Health Canada had granted marketing authorisation for Sandoz Semaglutide, a generic version of Ozempic, for once-weekly use in adults with type 2 diabetes. Sandoz described the Canadian GLP-1 market as worth USD 2.6 billion and said it foresaw no material contribution in 2026 from any potential launches of generic semaglutide.[src]
- Brazil: Owozy (July 2026)
- On 29 July 2026 Sandoz announced that Brazil's health regulator ANVISA had granted marketing authorisation for Owozy (semaglutide) for type 2 diabetes. Owozy was developed by Adalvo, and Sandoz will commercialise it in Brazil in partnership with Adalvo, with a launch expected in the second half of 2026. Sandoz said it foresaw no material contribution in 2026 from any potential launch of generic semaglutide.[src]
- US: generic tirzepatide applications (June 2026)
- On 29 June 2026 Sandoz announced that the US FDA had accepted for review two Abbreviated New Drug Applications for an in-house generic tirzepatide autoinjector, referencing Mounjaro and Zepbound. Acceptance for review is not an approval; Sandoz said any launch is subject to FDA approval.[src]
- Company scale
- In the same June 2026 release Sandoz states that it recorded net sales of USD 11.1 billion in 2025 and that its global portfolio comprises 1,300 generic medicines.[src]
Molecules
Key events
2026-09-18
Health Canada approves Sandoz's generic semaglutide
Sandoz Canada announced on 18 September 2026 that Health Canada had approved Sandoz Semaglutide, a generic version of Ozempic for adults with type 2 diabetes. It said it was preparing for commercialisation.[src]
Sources (4)
- 01Sandoz receives regulatory approval for generic semaglutide in Canada, paving way to expand patient access to key GLP-1 medicineSandoz Group AG (media release) · 2026-09-18 · accessed 2026-09-29
- 02Sandoz confirms regulatory approval for new semaglutide treatment option in Brazil, paving way to expand patient accessSandoz Group AG (media release) · 2026-07-29 · accessed 2026-09-29
- 03US FDA accepts Sandoz applications for proposed in-house development of generic tirzepatide GLP-1sSandoz Group AG (media release) · 2026-06-29 · accessed 2026-09-29
- 04Sandoz Canada receives Health Canada regulatory approval for Sandoz Semaglutide, a generic version of OzempicSandoz Canada (BioSpace) · 2026-09-18 · accessed 2026-09-29