Sandoz Launches Pyzchiva Autoinjector, First Commercially Available In Europe For Ustekinumab Biosimilars

• 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

Sandoz, 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.

^*Pyzchivais 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

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 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.