Sandoz launches biosimilar Pyzchiva® (ustekinumab) across Europe, to treat chronic inflammatory diseases
Sandoz has launched Pyzchiva® (ustekinumab), a biosimilar, across Europe to treat chronic inflammatory diseases. This launch strengthens Sandoz's immunology portfolio in Europe, marking their fifth biosimilar in this therapeutic area. Pyzchiva® is the first ustekinumab biosimilar in Europe offering all reference medicine strengths, including the 130mg vial initiation dose for Crohn's disease.
Pyzchiva® is approved to treat adults with plaque psoriasis, psoriatic arthritis, Crohn's disease, and pediatric plaque psoriasis for patients six years and older weighing over 60 kg. This launch is expected to contribute to Sandoz's mid-term growth strategy and aims to improve access to affordable medicines for millions of people with chronic inflammatory diseases in Europe.
Sandoz ha lanciato Pyzchiva® (ustekinumab), un biosimilare, in tutta Europa per trattare le malattie infiammatorie croniche. Questo lancio rafforza il portafoglio di immunologia di Sandoz in Europa, segnando il loro quinto biosimilare in questo campo terapeutico. Pyzchiva® è il primo biosimilare di ustekinumab in Europa che offre tutte le forme del medicinale di riferimento, compresa la dose di avvio da 130mg per la malattia di Crohn.
Pyzchiva® è approvato per trattare adulti con psoriasi a placche, artrite psoriasica, malattia di Crohn e psoriasi a placche pediatrica per pazienti di sei anni e oltre che pesano più di 60 kg. Questo lancio è previsto per contribuire alla strategia di crescita a medio termine di Sandoz e mira a migliorare l'accesso a medicinali accessibili per milioni di persone con malattie infiammatorie croniche in Europa.
Sandoz ha lanzado Pyzchiva® (ustekinumab), un biosimilar, en toda Europa para tratar enfermedades inflamatorias crónicas. Este lanzamiento refuerza el portafolio de inmunología de Sandoz en Europa, marcando su quinto biosimilar en esta área terapéutica. Pyzchiva® es el primer biosimilar de ustekinumab en Europa que ofrece todas las concentraciones del medicamento de referencia, incluyendo la dosis de inicio de 130 mg para la enfermedad de Crohn.
Pyzchiva® está aprobado para tratar adultos con psoriasis en placas, artritis psoriásica, enfermedad de Crohn y psoriasis en placas pediátrica para pacientes de seis años o más que pesen más de 60 kg. Se espera que este lanzamiento contribuya a la estrategia de crecimiento a medio plazo de Sandoz y tenga como objetivo mejorar el acceso a medicamentos asequibles para millones de personas con enfermedades inflamatorias crónicas en Europa.
산도즈(Sandoz)가 피즈치바(Pyzchiva®) (우스테키누맙)를 유럽 전역에 출시하여 만성 염증 질환을 치료하고 있습니다. 이번 출시로 산도즈의 면역학 포트폴리오가 유럽에서 강화되며, 이 치료 분야에서 다섯 번째 바이오시밀러가 됩니다. 피즈치바(Pyzchiva®)는 모든 기준 의약품 강도를 제공하는 유럽 최초의 우스테키누맙 바이오시밀러로, 크론병에 대한 130mg 유리 용량 출시를 포함합니다.
Pyzchiva®는 판상 건선, 건선 관절염, 크론병 및 60kg 이상의 어린이 환자를 대상으로 하는 판상 건선 치료를 위해 성인에게 승인되었습니다. 이번 출시가 산도즈의 중기 성장 전략에 기여할 것으로 기대되며, 유럽의 만성 염증 질환을 앓고 있는 수백만 명에게 저렴한 의약품 접근성을 향상시키는 것을 목표로 합니다.
Sandoz a lancé Pyzchiva® (ustekinumab), un biosimilaire, dans toute l'Europe pour traiter les maladies inflammatoires chroniques. Ce lancement renforce le portefeuille d'immunologie de Sandoz en Europe, marquant leur cinquième biosimilaire dans ce domaine thérapeutique. Pyzchiva® est le premier biosimilaire d'ustekinumab en Europe à offrir toutes les forces du médicament de référence, y compris la dose d'initiation de 130 mg pour la maladie de Crohn.
Pyzchiva® est approuvé pour traiter les adultes atteints de psoriasis en plaques, d'arthrite psoriasique, de maladie de Crohn et de psoriasis en plaques pédiatrique pour les patients âgés de six ans et plus pesant plus de 60 kg. Ce lancement devrait contribuer à la stratégie de croissance à moyen terme de Sandoz et vise à améliorer l'accès à des médicaments abordables pour des millions de personnes souffrant de maladies inflammatoires chroniques en Europe.
Sandoz hat Pyzchiva® (Ustekinumab), ein Biosimilar, in ganz Europa eingeführt, um chronische entzündliche Erkrankungen zu behandeln. Dieser Launch stärkt das Immunologie-Portfolio von Sandoz in Europa und markiert ihr fünftes Biosimilar in diesem therapeutischen Bereich. Pyzchiva® ist das erste Ustekinumab-Biosimilar in Europa, das alle Stärken des Referenzmedikaments anbietet, einschließlich der 130 mg Anfangsdosis für Morbus Crohn.
Pyzchiva® ist zur Behandlung von Erwachsenen mit Plaque-Psoriasis, psoriatischer Arthritis, Morbus Crohn und pädiatrischer Plaque-Psoriasis für Patienten ab sechs Jahren mit einem Gewicht von über 60 kg zugelassen. Dieses Launch wird voraussichtlich zur mittel- bis langfristigen Wachstumsstrategie von Sandoz beitragen und zielt darauf ab, den Zugang zu erschwinglichen Medikamenten für Millionen von Menschen mit chronischen entzündlichen Erkrankungen in Europa zu verbessern.
- Launch of Pyzchiva® strengthens Sandoz's immunology portfolio in Europe
- First ustekinumab biosimilar in Europe with all reference medicine strengths
- Expands treatment options for multiple chronic inflammatory diseases
- Contributes to Sandoz's mid-term growth strategy
- Leverages existing European footprint with five biosimilars in immunology
- None.
Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules
Sandoz launches biosimilar Pyzchiva® (ustekinumab) across Europe, to treat chronic inflammatory diseases
- Launch across Europe, starting today, strengthens well-established Sandoz immunology portfolio in Europe, leveraging existing footprint
- Pyzchiva® first ustekinumab biosimilar to launch in Europe with all reference medicine strengths, including 130mg vial initiation dose for Crohn’s disease
- Pyzchiva® to treat adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and pediatric plaque psoriasis
Basel, July 25, 2024 – Sandoz, the global leader in generic and biosimilar medicines, announces the launch of Pyzchiva®* (ustekinumab) across Europe, starting today. Pyzchiva®, developed and registered by Samsung Bioepis, is the first ustekinumab biosimilar to launch in Europe with all reference medicine strengths, including the 130mg vial initiation dose for Crohn’s disease.
The launch strengthens our well-established immunology portfolio in Europe and leverages our existing footprint, with five biosimilars now marketed in this therapeutic area. Pyzchiva® is a key biosimilar driver, adding value and contributing to the company’s mid-term growth strategy.
Rebecca Guntern, President Europe, Sandoz, said: “Timely and expanded access to safe, effective and affordable medicines can improve quality of life for millions of people living with chronic inflammatory diseases. Our goal is to make potentially life-changing medicines accessible to patients across Europe. Pyzchiva® is one of the first ustekinumab biosimilars in Europe, which marks a significant milestone on that road.”
Pyzchiva® is approved for 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.
Europe has the highest prevalence of psoriasis worldwide, affecting an estimated 6.4 million people and significantly impacting patients’ quality of life.1,2 Plaque psoriasis is the most common form of psoriasis, affecting
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, 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.
**Stelara® is a trademark of Johnson & Johnson
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 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.
Pyzchiva® is available as a 130 mg concentrate in a vial for solution for infusion, additionally, a 90 mg and a 45 mg concentrate solution for injection in a pre-filled syringe.
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
- 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 July 2024].
- 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.
- 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;7:201-10.
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 annually 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.
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FAQ
What is Pyzchiva® and what conditions does it treat?
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