Sandoz confirms European Commission approval of Pyzchiva® (ustekinumab), further strengthening immunology offering

Rhea-AI Summary

Sandoz receives European Commission approval for Pyzchiva® (ustekinumab), a key biosimilar therapy within gastroenterology, dermatology, and rheumatology, further strengthening their immunology portfolio. The approval is based on a robust development program confirming safety, efficacy, and quality match to the reference medicine. Sandoz remains committed to providing access to life-changing treatments.

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

• Pyzchiva^® approved as one of first ustekinumab biosimilars in Europe
• EC approval based on robust development program confirming match to reference medicine in terms of safety, efficacy and quality
• Sandoz remains committed to accelerating access to potentially life-changing treatments and continues strengthening immunology portfolio

Basel, April 22, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announces that the European Commission (EC) has granted marketing authorization for Pyzchiva^®* (biosimilar ustekinumab), developed and registered by Samsung Bioepis. Pyzchiva^® is a key biosimilar value driver for the company over the mid-term and this approval is a major step in advancing Sandoz growth strategy.

Pyzchiva^® is approved as a biologic therapy within gastroenterology, dermatology, and rheumatology.¹

Rebecca Guntern, President Sandoz Europe, said: "Chronic inflammatory diseases affect millions of people around the world and can have a profoundly negative impact on their quality of life. This approval is a crucial step towards offering European patients an additional safe and effective treatment option and further demonstrates our commitment to pioneer access to potentially life-changing medicines."

The comprehensive regulatory submission package included extensive analytical, preclinical, and clinical data, including a Phase I PK/PD study and a Phase III confirmatory study.

Sandoz entered into a development and commercialization agreement for biosimilar ustekinumab with Samsung Bioepis in September 2023. Under the terms of the agreement, Sandoz has the right to commercialize Pyzchiva^® in the US, Canada, the European Economic Area (EEA), Switzerland, and the UK. Samsung Bioepis remains responsible for development, registration, intellectual property, manufacturing and supply.

* Pyzchiva^® is a trademark of Samsung Bioepis Co. Ltd.

About Pyzchiva^® (ustekinumab)
Pyzchiva^® (ustekinumab) has been developed to match the reference medicine, a monoclonal antibody medication to interleukin (IL)-12/23 for the treatment of autoimmune disorders including within gastroenterology, dermatology, and rheumatology. ¹

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 update or revise any forward-looking statements, except as required by law.

References

1. European Medicines Agency (EMA). Pzychiva^® (ustekinumab): Prescribing Information. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/pyzchiva [Last accessed April 2024].
2. International Federation of Psoriasis Associations (IFPA). Speaking up for psoriatic disease in Europe. Available at: https://cms.ifpa-pso.com/tools/20072022_IFPA-FORUM_Briefing-Book_Speaking-up.pdf [Last accessed April 2024].
3. Frede N, et al. Psoriasis and Psoriatic Arthritis Have a Major Impact on Quality of Life and Depressive Symptoms: A Cross-Sectional Study of 300 Patients. Rheumatology and Therapy. 2023;10: 1655–1668. doi: 10.1007/s40744-023-00602-9.
4. Kumar A, et al. Crossing barriers: the burden of inflammatory bowel disease across Western Europe. Therapeutic Advances in Gastroenterology. 2023;16. doi: 10.1177/17562848231218615.
5. Burisch J. et al. The burden of inflammatory bowel disease in Europe, Journal of Crohn's and Colitis, Volume 7, Issue 4, May 2013, P. 322–337
6. Pulley J, et al. Malnutrition and quality of life among adult inflammatory bowel disease patients. JGH Open. 2019;4(3): 454-460. doi: 10.1002/jgh3.12278.

About Sandoz
Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of more than 100 nationalities work together to ensure 800 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the first biosimilar in 2006. In 2023, Sandoz recorded sales of USD 9.6 billion.

Global Media Relations contacts	Investor Relations contacts
Global.MediaRelations@sandoz.com	Investor.Relations@sandoz.com
Joerg E. Allgaeuer +49 171 838 4838	Karen M. King +1 609 722 0982
Chris Lewis +49 174 244 9501	Laurent de Weck +41 79 795 7364

Attachment

• Sandoz Media Release ustekinumab

FAQ

What is the significance of the European Commission approval for Pyzchiva® (ustekinumab)?

The approval strengthens Sandoz's immunology portfolio and offers European patients an additional safe and effective treatment option within gastroenterology, dermatology, and rheumatology.

Who developed and registered Pyzchiva® (ustekinumab)?

Pyzchiva® was developed and registered by Samsung Bioepis.

What studies were included in the regulatory submission package for Pyzchiva® (ustekinumab)?

The regulatory submission package included extensive analytical, preclinical, and clinical data, including a Phase I PK/PD study and a Phase III confirmatory study.

What agreement did Sandoz enter into regarding biosimilar ustekinumab?

Sandoz entered into a development and commercialization agreement with Samsung Bioepis for biosimilar ustekinumab, allowing Sandoz to commercialize Pyzchiva® in certain regions.

What does Pyzchiva® (ustekinumab) approval mean for Sandoz's growth strategy?

Pyzchiva® approval is a major step in advancing Sandoz's growth strategy as it is considered a key biosimilar value driver for the company over the mid-term.