Twenty years of biosimilar medicines: a milestone that continues to transform patient access worldwide

Sandoz Group AG / Key word(s): Statement
Twenty years of biosimilar medicines: a milestone that continues to transform patient access worldwide

13.04.2026 / 07:00 CET/CEST

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MEDIA RELEASE

• Twentieth anniversary of European regulatory approval for Omnitrope (somatropin) as world's first-ever biosimilar medicine; Sandoz pioneered new industry

• More than USD 1.9 billion in savings generated for European healthcare systems through Omnitrope, with over 118 million patient treatment days provided

• Biosimilars overall generated EUR 56 billion in cumulative healthcare savings and provided nearly seven billion patient treatment days across Europe in last 20 years

• Coming 'golden decade' of ~USD 320 billion patent expiries offers huge potential to further transform healthcare

Basel, 13 April 2026 - Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, today celebrates the 20th anniversary of European regulatory approval for Omnitrope (somatropin) as the world's first-ever biosimilar medicine.

Omnitrope was approved by the European Medicines Agency on April 12 2006, and was subsequently launched in markets across Europe. It was approved later in 2006 in the US under a different regulatory pathway, before being approved as the first biosimilar in Canada and Japan in 2009.

Since launch, Omnitrope has led to more than USD 1.9 billion in savings for European healthcare systems and has provided over 118 million patient treatment days¹. Sandoz today remains the global leader in the multi-player somatropin market, having overtaken the reference medicine and with sales continuing to grow year on year².

Sandoz CEO Richard Saynor says: "The approval of Omnitrope 20 years ago marked a turning point in modern healthcare, ushering in a new era of competition, sustainability and expanded patient access. The European Commission established the first regulatory pathway for biosimilars, validating the core scientific principles that shaped a new global industry."

Mr. Saynor added: "And this was only the beginning. We now stand on the cusp of a 'golden decade' for patient care, with biologic medicines worth more than USD 320 billion due to lose patent protection over the next decade. At Sandoz, we are fully committed to playing a leading role as that opportunity unfolds."

Since this first approval, biosimilar medicines have generated cumulative healthcare savings of EUR 56 billion and have provided seven billion patient treatment days across Europe³. With approximately 120 biosimilars approved worldwide across a range of therapeutic areas⁴, they have grown to become a cornerstone of healthcare systems, transforming patient access to cutting-edge biologic therapies.

Today, Sandoz remains committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably, with a global portfolio comprising 13 biosimilars and a leading pipeline.

In 2026, Sandoz is celebrating three key milestones. In addition to the 20th anniversary of the Omnitrope approval in 2006, 140 years ago, Alfred Kern and Edouard Sandoz founded a company that would later evolve into a global leader in affordable medicines, while 80 years ago, in Kundl, Austria, a former brewery was converted into a factory that remains Europe's last major end-to-end penicillin facility.

ABOUT OMNITROPE (SOMATROPIN)
Omnitrope (somatropin) is a recombinant human growth hormone indicated for the treatment of growth disturbances in infants, children and adolescents, including those associated with growth hormone deficiency, Turner syndrome, chronic renal insufficiency, small for gestational age status, and Prader-Willi syndrome⁵. In adults, Omnitrope is indicated for replacement therapy in pronounced growth hormone deficiency, whether of adult onset or childhood onset origin⁵.

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 IQVIA. 15+ years of Biosimilar Experience in Europe: Omnitrope Case Study. Available at: 15+ Years of Biosimilar Experience in Europe | IQVIA. November 2022. [Last accessed: April 2026]. Patient days figure converted by Sandoz from original patient years.
² Based on IQVIA MIDAS and Sandoz internal data. Data on file
³ IQVIA. The Impact of Biosimilar Competition in Europe 2024. January 2025. Available at: https://www.iqvia.com/library/white-papers/the-impact-of-biosimilar-competition-in europe-2024 [Last accessed: April 2026]
⁴ Market Growth Reports. Biosimilar Market Size, Share, Growth, and Industry Analysis, By Type, By Application Regional Insights and Forecast to 2035. March 2026. Available at: Biosimilar Market Size | Research Report, 2025 To 2035 [Last accessed: April 2026]
⁵ European Medicines Agency (EMA). Omnitrope (Somatropin) Summary of Product Characteristics. Available at: Omnitrope, INN-somatropin [Last accessed, April 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.

CONTACTS

Global Media Relations contacts	Investor Relations contacts
[e-mail]	[e-mail]
Alexis Kalomparis [phone]	Craig Marks [phone]
Chris Lewis [phone]	Tamara Hackl [phone]
Gregor Rodehueser [phone]	Silvia Siegfried [phone]

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End of Media Release
View original content: EQS News

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Language:	English
Company:	Sandoz Group AG
	Centralbahnstrasse 4
	4051 Basel
	Switzerland
Internet:	www.sandoz.com
ISIN:	CH1243598427
Valor:	124359842
Listed:	SIX Swiss Exchange
EQS News ID:	2306216

End of News	EQS News Service

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2306216 13.04.2026 CET/CEST