STADA and Alvotech launch Uzpruvo, the first approved ustekinumab biosimilar to Stelara, across Europe
STADA and Alvotech have launched Uzpruvo, the first approved ustekinumab biosimilar to Stelara, across major European markets. This launch comes immediately after the expiry of exclusivity rights for the reference molecule, creating competition and potentially broadening patient access in a market estimated at €2.4 billion. Uzpruvo is indicated for Crohn's disease, psoriatic arthritis, and plaque psoriasis in adults and children from 6 years old.
Uzpruvo offers a pre-filled syringe with a thinner needle and is latex-free. It's the second immunology biosimilar brought to market through the STADA-Alvotech partnership, following the 2022 launch of Hukyndra (adalimumab). The biosimilar is developed, manufactured, and packaged entirely within Europe, with a 36-month shelf life.
STADA e Alvotech hanno lanciato Uzpruvo, il primo biosimilare di ustekinumab approvato per Stelara, nei principali mercati europei. Questo lancio avviene subito dopo la scadenza dei diritti di esclusiva per la molecola di riferimento, creando concorrenza e potenzialmente ampliando l'accesso per i pazienti in un mercato stimato di 2,4 miliardi di euro. Uzpruvo è indicato per la malattia di Crohn, l'artrite psoriasica e la psoriasi a placche negli adulti e nei bambini a partire dai 6 anni.
Uzpruvo offre una siringa pre-riempita con un ago più sottile ed è priva di lattice. Si tratta del secondo biosimilare in immunologia portato sul mercato grazie alla partnership STADA-Alvotech, dopo il lancio di Hukyndra (adalimumab) nel 2022. Il biosimilare è sviluppato, prodotto e confezionato interamente in Europa, con una durata di conservazione di 36 mesi.
STADA y Alvotech han lanzado Uzpruvo, el primer biosimilar de ustekinumab aprobado para Stelara, en los principales mercados europeos. Este lanzamiento se produce inmediatamente después de la expiración de los derechos de exclusividad de la molécula de referencia, creando competencia y potencialmente ampliando el acceso de los pacientes en un mercado estimado en 2.4 mil millones de euros. Uzpruvo está indicado para la enfermedad de Crohn, la artritis psoriásica y la psoriasis en placas en adultos y niños a partir de 6 años.
Uzpruvo ofrece una jeringa precargada con una aguja más delgada y es libre de látex. Es el segundo biosimilar en inmunología lanzado al mercado a través de la asociación STADA-Alvotech, después del lanzamiento de Hukyndra (adalimumab) en 2022. El biosimilar es desarrollado, fabricado y empaquetado completamente en Europa, con una vida útil de 36 meses.
STADA와 Alvotech가 주요 유럽 시장에서 제일 처음 승인된 우스테키누맙 바이오시밀러 Uzpruvo를 출시했습니다. 이 출시는 기준 분자의 독점 권리가 만료된 직후에 이루어져 경쟁을 초래하고 환자의 접근성을 잠재적으로 넓히며 24억 유로로 추정되는 시장에서 기회를 제공합니다. Uzpruvo는 크론병, 건선성 관절염 및 판상 건선 치료에 어린이와 성인 모두에게 사용됩니다.
Uzpruvo는 얇은 바늘을 가진 프리필드 주사기를 제공하며 라텍스가 없습니다. 이는 2022년 Hukyndra(아달리무맙) 출시 후 STADA-Alvotech 파트너십을 통해 시장에 출시된 두 번째 면역학 바이오시밀러입니다. 이 바이오시밀러는 완전히 유럽 내에서 개발되고 제조되며 포장됩니다, 유통 기한은 36개월입니다.
STADA et Alvotech ont lancé Uzpruvo, le premier biosimilaire d'ustekinumab approuvé pour Stelara, sur les principaux marchés européens. Ce lancement intervient immédiatement après l'expiration des droits d'exclusivité de la molécule de référence, créant une concurrence et élargissant potentiellement l'accès des patients dans un marché estimé à 2,4 milliards d'euros. Uzpruvo est indiqué pour la maladie de Crohn, l'arthrite psoriasique et le psoriasis en plaques chez les adultes et les enfants à partir de 6 ans.
Uzpruvo offre une seringue préremplie avec une aiguille plus fine et est sans latex. C'est le deuxième biosimilaire en immunologie lancé sur le marché grâce au partenariat STADA-Alvotech, après le lancement de Hukyndra (adalimumab) en 2022. Le biosimilaire est développé, fabriqué et emballé entièrement en Europe, avec une durée de conservation de 36 mois.
STADA und Alvotech haben Uzpruvo, das erste zugelassene Ustekinumab-Biosimilar zu Stelara, auf den wichtigsten europäischen Märkten eingeführt. Dieser Launch erfolgt unmittelbar nach dem Ablauf der Exklusivrechte für das Referenzmolekül, wodurch Konkurrenz entsteht und möglicherweise der Patienten Zugriff auf einen Markt, der auf 2,4 Milliarden Euro geschätzt wird, erweitert wird. Uzpruvo ist angezeigt für Morbus Crohn, psoriatische Arthritis und Plaque-Psoriasis bei Erwachsenen und Kindern ab 6 Jahren.
Uzpruvo bietet eine fertige Spritze mit einer dünneren Nadel und ist latexfrei. Es ist das zweite Immunologie-Biosimilar, das durch die Partnerschaft von STADA und Alvotech auf den Markt gebracht wird, nach der Einführung von Hukyndra (Adalimumab) im Jahr 2022. Das Biosimilar wird komplett in Europa entwickelt, hergestellt und verpackt und hat eine Haltbarkeit von 36 Monaten.
- First-to-market ustekinumab biosimilar in Europe
- Immediate launch upon patent expiry in major European markets
- Potential to broaden patient access in a €2.4 billion market
- Pre-filled syringe with thinner needle and latex-free design
- 36-month shelf life
- Manufactured using nearly 100% renewable energy
- Not approved for ulcerative colitis indication due to originator's exclusivity
Impact on Market Competition and Pricing: The launch of Uzpruvo by STADA and Alvotech represents a significant milestone in the European biosimilar market. As the first approved ustekinumab biosimilar to Stelara, Uzpruvo's entry increases competition, likely leading to reduced prices for this important medication. This is pivotal in a market estimated at approximately €2.4 billion. Historically, the introduction of biosimilars has led to price reductions of between
Clinical and Patient Benefits: Uzpruvo's approval marks a breakthrough for patients with Crohn’s disease, psoriatic arthritis and plaque psoriasis. The early market entry allows for immediate patient access to a high-quality, cost-effective treatment. The thinner needle and latex-free syringe offer improved patient comfort and reduced allergic reaction risks. Importantly, having equivalent efficacy, safety, pharmacokinetics and immunogenicity to Stelara ensures that the switch for patients will be seamless, thereby maintaining treatment efficacy without additional risks. Clinicians may be more inclined to recommend Uzpruvo given its high-quality profile and the established experience of STADA in biosimilars.
Strategic Implications and Growth Opportunities: This launch reinforces STADA and Alvotech's position in the biosimilar market. Their strategic partnership has already seen success with the launch of Hukyndra and the planned biosimilar to Prolia/Xgeva. This pattern of successful product introductions could strengthen their market presence and credibility. The European-made supply chain is a notable advantage, ensuring reliability and alignment with regional sustainability commitments. For investors, this consistent pipeline of biosimilar launches presents a growth opportunity, potentially translating to increased revenue streams and market capitalization for both companies.
- Launch of European-made Uzpruvo in Europe comes immediately upon expiry of exclusivity rights for the molecule used to treat certain conditions in gastroenterology1, dermatology and rheumatology
- Creates competition at earliest opportunity, enabling straightforward switching to broaden patient access and control costs in a growing market, with accessible indications currently estimated at approximately
€2.4 billion - Ustekinumab is the second immunology biosimilar brought to market through the partnership between STADA and Alvotech, following the 2022 launch of the Hukyndra high-concentration adalimumab brand
BAD VILBEL, Germany and REYKJAVIK, Iceland, July 22, 2024 (GLOBE NEWSWIRE) -- STADA and Alvotech have launched Uzpruvo®, the first approved biosimilar to Stelara® in Europe, across a majority of European countries. This includes the largest markets in the region, where pricing and reimbursement approvals have been secured for market entry. The pioneering launch comes immediately upon expiry of exclusivity rights linked to the European reference molecule patent, offering patients, physicians and payers expanded access at the earliest possible opportunity to a life-altering medicine used in certain indications within gastroenterology1, dermatology and rheumatology. Launches in further European countries are scheduled over the coming months, following national price approvals, via a fully European supply chain.
“Launching Uzpruvo at the earliest opportunity in Europe’s largest pharmaceutical markets, promotes access by creating competition,” stated STADA CEO Peter Goldschmidt. “This opportunity to improve patient access through wider usage of a life-changing biological treatment emphasizes STADA’s purpose of Caring for People’s Health as a Trusted Partner.”
“We are delighted at the launch of Uzpruvo in Europe and to be first-to-market,” commented Robert Wessman, Chief Executive Officer of Alvotech. “This launch symbolizes the robustness of our platform, the value of our partnership with STADA, and our collective focus on the importance of biosimilars.”
In January 2024, Uzpruvo became the first ustekinumab biosimilar to be approved by the European Commission as having equivalent efficacy, safety, pharmacokinetics and immunogenicity to the Stelara® reference product.2 Uzpruvo is indicated for Crohn’s disease and psoriatic arthritis in adults, as well as plaque psoriasis in adults and children aged from 6 years. Uzpruvo® is currently not approved for the ulcerative colitis indication, since the originator still has exclusivity for this indication.
Uzpruvo is offered in a pre-filled syringe format featuring a thinner needle than the reference product and is latex-free to minimize the risk of allergic reactions. Uzpruvo was developed, and is manufactured and packaged, entirely within Europe, and has a 36-month shelf life.
“With comparable safety, efficacy and immunogenicity, Uzpruvo gives clinicians an opportunity for a seamless and simple switch for their patients, who can benefit from a thinner needle and latex-free syringe,” commented STADA’s Global Specialty Head, Bryan Kim. “Physicians and patients can have full confidence that STADA has more than 15 years of experience in enhancing patient access through high-quality biosimilars in Europe, having launched our first biosimilar in 2008.”
Ustekinumab is the second immunology biosimilar brought to market through the strategic partnership between STADA and Alvotech, following the 2022 launch of the Hukyndra high-concentration, citrate-free adalimumab therapy. The partners also recently announced a development, manufacturing and marketing alliance for a proposed biosimilar to Prolia®/Xgeva® (denosumab) candidate, AVT03. Alvotech is responsible for development and manufacturing of biosimilars within the partnership at its facility in Reykjavik, Iceland, that benefits from nearly
Overall, Uzpruvo is STADA’s seventh biosimilar supplied in Europe, with the German group also offering biosimilars in the bone health, nephrology, oncology and ophthalmology therapeutic sectors, alongside differentiated specialty therapies in nephrology and neurology.
Alvotech is a global leader in the biosimilar space and boasts a portfolio and pipeline of 11 biosimilars and biosimilar candidates covering a wide variety of indications. Alvotech, through its partnership network has now launched biosimilar to Stelara in Canada, Japan, and now in Europe.
About STADA Arzneimittel AG
STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a three-pillar strategy consisting of consumer healthcare products, generics and specialty pharma. Worldwide, STADA Arzneimittel AG sells its products in approximately 115 countries. In financial year 2023, STADA achieved group sales of EUR 3,735 million and reported earnings before interest, taxes, depreciation and amortization (EBITDA) of EUR 802 million. As of 31 December 2023, STADA employed 11,667 people worldwide.
About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech has launched two biosimilars. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (US, EU), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
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1 Uzpruvo® is currently not approved for the ulcerative colitis indication, since the originator still has exclusivity for this indication
2 Union Register of medicinal products - Public health - European Commission (europa.eu)
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