Sandoz launches Pyzchiva® autoinjector, first commercially available in Europe for ustekinumab biosimilars

Rhea-AI Summary

Sandoz (SDZNY) has launched Pyzchiva®, Europe's first commercially available ustekinumab biosimilar autoinjector. The device, developed by Samsung Bioepis, is approved for treating adults with plaque psoriasis, psoriatic arthritis, Crohn's disease, and pediatric plaque psoriasis patients over 60kg. The autoinjector features improved self-administration capabilities, including accurate automatic dosing, reduced injection pain, and flexible storage options. Currently available in Spain, Pyzchiva® has been launched in 23 European markets. This launch is significant given Europe's high prevalence of psoriasis (6.4 million people) and inflammatory bowel diseases (2.5-3 million people). The product stems from Sandoz's September 2023 agreement with Samsung Bioepis, granting commercialization rights in Brazil, US, EEA, Switzerland, and UK.

Positive

• First ustekinumab biosimilar autoinjector in Europe, giving Sandoz first-mover advantage
• Improved features for patient comfort and adherence, potentially leading to better treatment outcomes
• Already launched in 23 European markets, showing strong market penetration
• Addresses large market with 6.4M psoriasis and 2.5-3M inflammatory bowel disease patients in Europe

Negative

• Limited initial availability (only in Spain, with gradual European rollout)
• Dependency on Samsung Bioepis for manufacturing and supply

MEDIA RELEASE

• Pyzchiva® first ustekinumab biosimilar in Europe commercially available in pre-filled pen (autoinjector), offering improved self-administration experience for better treatment adherence and quality of life [1-10]

• Autoinjector includes unique features to improve comfort, independence and convenience for patients with chronic inflammatory diseases [1-10]

• Launch strengthens Sandoz biosimilar leadership position in immunology and commitment to patient-centric innovation

Basel, May 21, 2025 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced the European launch of its Pyzchiva®* (ustekinumab) autoinjector.[1-2] This is the first ustekinumab biosimilar in Europe commercially available in an autoinjector. Developed and registered by Samsung Bioepis, Pyzchiva® is approved for the treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and pediatric plaque psoriasis for patients aged six years and older, weighing over 60 kg.[1]

The Pyzchiva® autoinjector supports a more comfortable self-administration experience [1-10] with accurate automatic dosing [1,3,4], less frequent injection pain [1,9,10], a compact design [1,3,4,6,7], and flexible storage options [1], offering the potential for improved adherence to patient treatment plans.

Christophe Delenta, President Europe, Sandoz, said: “Access to medicine does not end when it reaches the hands of the patient. The Pyzchiva® autoinjector, with its thoughtful and advanced features, addresses the real-world needs of patients in managing chronic inflammatory diseases. This launch marks another important milestone as we strengthen our leadership in immunology biosimilars and reaffirm our commitment to pioneering access across Europe’s evolving healthcare landscape.”

Europe has the highest prevalence of psoriasis worldwide, affecting an estimated 6.4 million people.[11-13] Inflammatory bowel diseases, such as Crohn’s disease, are also common in Europe, affecting an estimated 2.5 to 3 million people.[14] Non-adherence to biologic therapies can lead to disease progression, increased flares and reduced quality of life, while contributing to increased healthcare utilization, including hospitalizations and additional treatments, thereby escalating healthcare costs.[15,16]

Pyzchiva® is a key biosimilar value driver for the Sandoz growth strategy. It has been launched in 23 markets in Europe. The autoinjector is now available in Spain and will continue to roll out across Europe.

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 Brazil, the US, the European Economic Area (EEA), Switzerland and the UK. Samsung Bioepis remains responsible for development, registration, intellectual property, manufacturing and supply.

ABOUT PYZCHIVA® (USTEKINUMAB)
Pyzchiva® (ustekinumab) has been developed as a biosimilar with equivalent efficacy and comparable safety to the reference medicine Stelara®**, a human monoclonal antibody against interleukin (IL)-12/23. Pyzchiva® is approved for the treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and pediatric plaque psoriasis for patients six years and older weighing over 60 kg.

The Pyzchiva® autoinjector is a pre-filled pen delivered through the Molly®*** platform of SHL Medical AG. It is available as a 90 mg in 1 mL autoinjector or a 45 mg in 0.5 mL autoinjector.[1,2]

Pyzchiva® is also available as a 130mg concentrate in a vial for solution for infusion, a 90 mg and a 45 mg concentrate solution for injection in a pre-filled syringe.

*Pyzchiva® is a trademark of Samsung Bioepis Co. Ltd.
**Stelara® is a trademark of Johnson & Johnson
***Pyzchiva® will be delivered by SHL Medical’s patented Molly® technology. Molly® is a registered trademark of SHL Medical AG

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] Pyzchiva® (ustekinumab) Summary of Product Characteristics. Available at: ema.europa.eu/en/documents/product-information/pyzchiva-epar-product-information_en.pdf (Accessed May 2025).
[2] Samsung Bioepis. Data on file.
[3] SHL Medical AG. Molly® autoinjector white paper. Available at: shl-medical.com/news-insights/downloads (Accessed May 2025).
[4] SHL Medical AG. Molly® SE autoinjector letter. April 16, 2025. Data on file.
[5] Paul C, Stalder JF, Thaçi D, et al. Patient satisfaction with injection devices: a randomized controlled study comparing two different etanercept delivery systems in moderate to severe psoriasis. J Eur Acad Dermatol Venereol. 2012;26:448–455.
[6] Tischer B, Mehl A. Patients’ and nurses’ preferences for autoinjectors for rheumatoid arthritis: results of a European survey. Patient Prefer Adherence. 2018;12:1413–1424.
[7] Thakur K, Sandhu SK, Sharma A. Patient Perceptions and Preferences of Two Etanercept Autoinjectors for Rheumatoid Arthritis: Findings from a Patient Survey in Europe. Rheumatol Ther. 2016;3:245–256.
[8] Lopez A, Mounier M, Bouvier AM, et al.Adherence to anti-TNF therapy in inflammatory bowel diseases: a systematic review. Inflamm Bowel Dis. 2013;19:1528–1533.
[9] Arendt-Nielsen L, Petersen-Felix S, Fischer M, Bak P. Pain following controlled cutaneous insertion of needles with different diameters. Somatosens Mot Res. 2006;23:37–43.
[10] Gill HS, Prausnitz MR. Does needle size matter? J Diabetes Sci Technol. 2007;1:725–729.
[11] International Federation of Psoriasis Associations (IFPA). Speaking up for psoriatic disease in Europe. Available at: ifpa-pso.com/content/tools/20072022_IFPA-FORUM_Briefing-Book_Speaking-up.pdf (Accessed May 2025).
[12] Frede N, Gerdes S, Schön MP, et al. Psoriasis and psoriatic arthritis have a major impact on quality of life and depressive symptoms: a cross-sectional study of 300 patients. Rheumatol Ther. 2023;10:1655–1668.
[13] Palfreeman AC, McNamee KE, McCann FE. New developments in the management of psoriasis and psoriatic arthritis: a focus on apremilast. Drug Des Devel Ther. 2013;7:201–210.
[14] Burisch J, Jess T, Martinato M, et al. The burden of inflammatory bowel disease in Europe. J Crohns Colitis. 2013;7:322–337.
[15] Vangeli E, Bakhshi S, Baker A, et al. A systematic review of factors associated with non-adherence to treatment for immune-mediated inflammatory diseases. Adv Ther. 2015;32:983–1028.
[16] Maniadakis N, Toth E, Schiff M, et al. A targeted literature review examining biologic therapy compliance and persistence in chronic inflammatory diseases. Adv Ther. 2018;35:1333–1355.

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 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 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 world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion.

CONTACTS

Global Media Relations	Investor Relations
Global.MediaRelations@sandoz.com	Investor.Relations@sandoz.com
Alex Kalomparis +41 79 279 0285	Craig Marks +44 7818 942 383
Joerg E. Allgaeuer +49 171 838 4838	Rupreet Sandhu +41 79 410 5472

Attachment

• Media release_Pyzchiva autoinjector European launch.pdf

FAQ

What is Sandoz SDZNY Pyzchiva autoinjector and what conditions does it treat?

Pyzchiva is Europe's first ustekinumab biosimilar autoinjector, approved for treating plaque psoriasis, psoriatic arthritis, Crohn's disease in adults, and pediatric plaque psoriasis for patients over 60kg.

What are the key features of Sandoz's Pyzchiva autoinjector?

The Pyzchiva autoinjector features accurate automatic dosing, reduced injection pain, compact design, and flexible storage options, designed to improve patient self-administration experience.

Where is Sandoz's Pyzchiva autoinjector currently available?

Pyzchiva has been launched in 23 European markets, with current availability in Spain and planned rollout across other European countries.

What is the market size for Sandoz's Pyzchiva in Europe?

The potential market includes 6.4 million people with psoriasis and 2.5-3 million people with inflammatory bowel diseases in Europe, which has the highest psoriasis prevalence worldwide.

What is the partnership between Sandoz and Samsung Bioepis for Pyzchiva?

Under a September 2023 agreement, Samsung Bioepis develops and manufactures Pyzchiva, while Sandoz has commercialization rights in Brazil, US, EEA, Switzerland, and UK.