Sandoz Marks 20 Years of Omnitrope Milestone Highlighting the Growth and Impact of Biosimilars in Global Healthcare

Sandoz Marks 20 Years of Omnitrope Milestone Highlighting the Growth and Impact of Biosimilars in Global Healthcare

(IN BRIEF) Sandoz is celebrating 20 years since the approval of Omnitrope, the world’s first biosimilar medicine, which helped establish a new pharmaceutical category and expand patient access to biologic treatments. Since its launch, Omnitrope has generated significant healthcare savings and delivered millions of treatment days across Europe. Biosimilars overall have contributed billions in savings and are expected to play an even larger role as major biologic drugs lose patent protection in the coming decade. Sandoz continues to invest in expanding its biosimilar portfolio to support affordable and sustainable healthcare globally.

(PRESS RELEASE) BASEL, 13-Apr-2026 — /EuropaWire/ — Sandoz is marking a major milestone in the evolution of modern healthcare, celebrating 20 years since the European approval of Omnitrope—the world’s first biosimilar medicine. The approval, granted by the European Medicines Agency in April 2006, set the foundation for an entirely new segment within the pharmaceutical industry and expanded access to biologic therapies worldwide.

Following its initial approval in Europe, Omnitrope was subsequently introduced across multiple markets, including the United States later in 2006 through a different regulatory pathway, and later in Canada and Japan in 2009 as the first biosimilar in those regions. Over the past two decades, the medicine has played a significant role in reducing healthcare costs and increasing treatment availability.

Since its launch, Omnitrope has contributed more than USD 1.9 billion in savings for European healthcare systems and delivered over 118 million patient treatment days. Today, Sandoz continues to hold a leading position in the global somatropin market, with sustained growth and strong adoption.

Richard Saynor, CEO of Sandoz, described the original approval as a defining moment that introduced competition into the biologics space while improving sustainability and access. He noted that the regulatory framework established in Europe validated the scientific principles underpinning biosimilars and helped shape a global industry that continues to evolve.

The broader impact of biosimilars has been substantial. Over the past 20 years, these medicines have generated approximately EUR 56 billion in cumulative savings across Europe while enabling nearly seven billion patient treatment days. With around 120 biosimilars now approved globally across multiple therapeutic areas, they have become a critical component of healthcare systems, supporting wider patient access to advanced treatments.

Looking ahead, Sandoz highlights the opportunity presented by a wave of upcoming patent expirations. Biologic medicines with a combined value of roughly USD 320 billion are expected to lose patent protection over the next decade, opening the door for expanded biosimilar adoption and further healthcare transformation. The company aims to play a central role in this next phase, often described as a “golden decade” for biosimilars.

Sandoz continues to focus on delivering affordable biologic therapies, supported by a growing global portfolio that currently includes 13 biosimilars and an extensive development pipeline. Its long-term strategy centers on improving patient access while maintaining sustainable healthcare systems.

In addition to the Omnitrope milestone, Sandoz is also marking two other anniversaries in 2026: the 140th anniversary of the company’s founding by Alfred Kern and Edouard Sandoz, and the 80th anniversary of its Kundl, Austria facility, which remains one of Europe’s last major integrated penicillin production sites.

Omnitrope, a recombinant human growth hormone, is used to treat a range of growth disorders in children and adolescents, including growth hormone deficiency, Turner syndrome, chronic renal insufficiency, small for gestational age conditions, and Prader–Willi syndrome. It is also prescribed for adults requiring growth hormone replacement therapy.

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.

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SOURCE: Sandoz