Alvotech and Advanz Pharma Receive Marketing Approval Across the European Economic Area for Gobivaz®, a First-in-Market Biosimilar to Simponi® (golimumab)
Alvotech (NASDAQ: ALVO) and Advanz Pharma announced that the European Commission granted marketing authorizations across the EEA for Gobivaz® (golimumab biosimilar) on Nov 20, 2025.
The approvals cover 50 mg/0.5 mL and 100 mg/mL in pre-filled syringe and autoinjector formats for adult indications including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, ulcerative colitis, and for juvenile idiopathic arthritis in children aged 2 years and older.
The EC decision follows a positive CHMP opinion in September and relied on analytical and clinical data, including positive confirmatory study topline results announced in April 2024.
Alvotech (NASDAQ: ALVO) e Advanz Pharma hanno annunciato che la Commissione Europea ha concesso le autorizzazioni all'immissione in commercio in tutto lo SEE per Gobivaz® (biosimile di golimumab) il 20 novembre 2025.
Le approvazioni coprono 50 mg/0,5 mL e 100 mg/mL in formati siringa pre-riempita e autoiniettore per indicazioni negli adulti tra cui artrite reumatoide, artrite psoriasica, spondiloartrite assiale, colite ulcerosa, e per l'artrite idiopatica giovanile nei bambini di età 2 anni e oltre.
La decisione della CE segue un parere positivo del CHMP a settembre ed è basata su dati analitici e clinici, inclusi i positivi risultati principali dello studio di conferma annunciati nell'aprile 2024.
Alvotech (NASDAQ: ALVO) y Advanz Pharma anunciaron que la Comisión Europea concedió autorizaciones de comercialización en todo el EEE para Gobivaz® (biosimilar de golimumab) el 20 de noviembre de 2025.
Las aprobaciones cubren 50 mg/0,5 mL y 100 mg/mL en formatos de jeringa prellenada y autoinyector para indicaciones en adultos que incluyen artritis reumatoide, artritis psoriásica, espondiloartritis axial, colitis ulcerosa, y para la artritis idiopática juvenil en niños de 2 años y más.
La decisión de la CE sigue a una opinión positiva del CHMP en septiembre y se basó en datos analíticos y clínicos, incluidos resultados finales del estudio de confirmación anunciados en abril 2024.
Alvotech (NASDAQ: ALVO)와 Advanz Pharma는 Gobivaz®(골리무맙 바이오의약품의 바이오시밀러) 마케팅 승인을 EEA 전역으로 부여했다고 2025년 11월 20일 발표했습니다.
승인은 50 mg/0.5 mL 및 100 mg/mL의 프리필드 주사기 및 자동주입기 형식으로 성인 적응증인 류마티스 관절염, 건선성 관절염, 축성 척추염, 궤양성 대장염, 그리고 2세 이상의 소아 특발성 관절염에 적용됩니다.
유럽 연합의 결정은 9월의 CHMP 의견에 따른 것이며 분석 및 임상 데이터에 기반합니다. 확인 연구의 상위 결과는 2024년 4월에 발표되었습니다.
Alvotech (NASDAQ: ALVO) et Advanz Pharma ont annoncé que la Commission européenne a accordé des autorisations de mise sur le marché dans l'EEE pour Gobivaz® (biosimilaire du golimumab) le 20 novembre 2025.
Les autorisations couvrent 50 mg/0,5 mL et 100 mg/mL dans des formats seringue pré-remplie et autoinjecteur pour des indications adultes comprenant la polyarthrite rhumatoïde, l’arthrite psoriasique, l’arthrite axiale (spondylarthrite axiale), la colite ulcéreuse, et pour l’arthrite idiopathique juvénile chez les enfants âgés de 2 ans et plus.
La décision de la CE fait suite à un avis positif du CHMP en septembre et s’appuie sur des données analytiques et cliniques, y compris les résultats principaux de l’étude de confirmation annoncés en avril 2024.
Alvotech (NASDAQ: ALVO) und Advanz Pharma gaben bekannt, dass die Europäische Kommission am 20. November 2025 Marktzulassungen im EEA für Gobivaz® (Golimumab-Biosimilar) erteilt hat.
Die Zulassungen umfassen 50 mg/0,5 ml und 100 mg/ml in vorkonfektionierten Spritzen und Autoinjektor-Formaten für erwachsene Indikationen einschließlich rheumatoider Arthritis, Psoriasis-Arthritis, axiale Spondyloarthritis, Colitis ulcerosa und für juvenile idiopathische Arthritis bei Kindern ab 2 Jahren.
Die EC-Entscheidung folgt auf eine positive CHMP-Empfehlung im September und basierte auf analytischen und klinischen Daten, einschließlich positiver Topline-Ergebnisse der bestätigenden Studie, die im April 2024 bekannt gegeben wurden.
ألڤوتيك (بورصة ناسداك: ALVO) و Advanz Pharma أعلنتا أن المفوضية الأوروبية منحت تصاريح التسويق عبر المنطقة الاقتصادية الأوروبية لـ Gobivaz® (نظير بيولوجي للجوليموماب) في 20 نوفمبر 2025.
تشمل الموافقات 50 mg/0.5 mL و 100 mg/mL في صيغ محقنة مسبقاً وجهاز حقن تلقائي لاستخدام الكبار من ضمنها التهاب المفاصل الروماتويدي، التهاب المفاصل الصدفي، الالتهاب العظمي القطني المحوري، التهاب القولون التقرحي، ولدى مرضى التهاب المفاصل الشبابي مجهول السبب في الأطفال الذين تبلغ أعمارهم 2 سنوات فأكثر.
تأتي قرار EC بعد رأي CHMP الإيجابي في سبتمبر واعتمد على البيانات التحليلية والسريرية، بما في ذلك نتائج الدراسة التأكيدية التي أُعلنت في أبريل 2024.
- EC marketing authorization granted across the EEA on Nov 20, 2025
- First biosimilar to Simponi (golimumab) approved in the European market
- Approvals include pediatric indication: juvenile idiopathic arthritis from age 2
- Covers two strengths and two delivery formats, aiding clinical adoption
- Approval supported by positive confirmatory clinical topline results April 2024
- Advanz holds exclusive EEA and UK commercialization rights
- None.
Insights
EC marketing authorization for Gobivaz® grants first-in-market golimumab biosimilar status in the EEA, enabling Advanz commercial launch under the partners' agreement.
Alvotech supplied the development and clinical evidence while Advanz Pharma holds registration and exclusive commercialization rights in the EEA and UK. The approval covers 50 mg and 100 mg formats, both pre-filled syringe and autoinjector, and multiple indications including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, ulcerative colitis, and juvenile idiopathic arthritis in children aged two and older. The EC decision follows a CHMP positive opinion and relies on the totality of evidence, including the confirmatory rheumatoid arthritis study and the pharmacokinetic study cited.
The business impact depends on successful regulatory-to-commercial handoff and payer acceptance in the EEA and UK. The partnership model concentrates development and supply with one party and registration and sales with the other, so execution risk centers on Advanz's market rollout and pricing negotiations. Also monitor manufacturing supply continuity and any post-approval safety commitments that derive from the submitted clinical programs.
Key items to watch in the next 6-12 months include timing of product launches across major EEA markets and the UK, local reimbursement and tender outcomes, initial uptake against the reference biologic, and any published post-marketing safety or pharmacovigilance reports. The stated clinical studies from
REYKJAVIK, Iceland and LONDON, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Commission (EC) has granted marketing authorizations in the European Economic Area (EEA) for Gobivaz®, Alvotech’s biosimilar to Simponi® (golimumab).
The authorizations cover Gobivaz® 50 mg/0.5 mL and 100mg/mL in both pre-filled syringe with passive needle safety guard and autoinjector formats, for the treatment of adults with rheumatoid arthritis in combination with methotrexate, psoriatic arthritis with or without methotrexate, axial spondyloarthritis, ulcerative colitis and for the treatment of juvenile idiopathic arthritis in children 2 years of age and older in combination with methotrexate. The approvals apply across the European Economic Area. The EC approval follows the positive opinion issued in September by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
“This milestone marks the second biosimilar to receive approval through our partnership with Advanz Pharma and further strengthens the commercial presence we are building in Europe. As the first biosimilar to Simponi® (golimumab) to gain approval in the European market, we are committed to expanding access to high quality biologic medicines for people living with immune-mediated diseases while providing value to healthcare systems throughout the region,” said Robert Wessman, Chairman and Chief Executive Officer of Alvotech.
“We welcome the EC approval of Gobivaz®, an important milestone in our partnership with Alvotech. Expanding access to high-quality biosimilars is central to Advanz Pharma’s mission, and this approval enables us to offer patients across Europe a valuable new treatment option for immune-mediated diseases,” said Steffen Wagner, Chief Executive Officer, Advanz Pharma.
Under the partnership between Alvotech and Advanz Pharma, Alvotech is responsible for the development and commercial supply of Gobivaz®, while Advanz Pharma holds the registration and exclusive commercialization rights in the EEA and the UK.
The EC approval of Gobivaz® was based on a totality of evidence, including analytical and clinical data. In April 2024, Alvotech announced positive top-line results from a confirmatory clinical study comparing efficacy, safety, and immunogenicity between its biosimilar candidate AVT05 and the reference product Simponi® in patients with moderate to severe rheumatoid arthritis (clintrials.gov/study/NCT05842213). In November 2023, Alvotech announced positive topline results from a pharmacokinetic study which assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® in healthy adult participants (clintrials.gov/study/NCT05632211).
About AVT05
AVT05 (golimumab) has been approved as Golimumab BS (golimumab) in Japan and as Gobivaz (golimumab) in the European Economic Area. Dossiers are under review in multiple countries globally. Golimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha (TNF alpha). Elevated TNF alpha levels have been implicated in several chronic inflammatory diseases such as rheumatoid arthritis [1].
Sources
[1] Simponi product information
Use of Trademarks
Simponi® is a registered trademark of Johnson & Johnson. Gobivaz® is a trademark of Advanz Pharma.
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’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has established 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), 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.
About Advanz Pharma
Partner of choice in specialty, hospital, and rare disease medicines. Advanz Pharma is a global pharmaceutical company with the purpose to improve patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialization partner network. Advanz Pharma’s product portfolio and pipeline comprises innovative medicines, biosimilars & specialty generics, and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, rheumatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Our ambition is to be a partner of choice for the commercialization of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with biopharma and development companies to bring medicines to patients. We can only achieve this due to our dedicated and highly qualified employees, acting in line with our company values of entrepreneurship, speed, and integrity.
Alvotech Forward Looking Statements
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.
Advanz Pharma Forward Looking Statements
Certain statements in this press release are forward-looking statements. These statements may be identified by words such as “anticipate”, "expectation", "belief', "estimate", "plan", "target”, “project”, “will”, “may”, “should” or "forecast" and similar expressions, or by their context. Although Advanz Pharma believes that these assumptions were reasonable when made, by their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions affecting the industry, intense competition in the markets in which Advanz Pharma operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting Advanz Pharma’s markets, and other factors beyond the control of Advanz Pharma. Neither Advanz Pharma nor any of its directors, officers, employees, advisors, or any other person is under any obligation to update or keep current the information contained in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this press release. Statements contained in this press release regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. No obligation is assumed to update any forward-looking statements. The information contained in this press release is provided as at the date of this document and is subject to change without notice.
MEDIA CONTACTS
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FAQ
What did Alvotech (ALVO) announce on Nov 20, 2025 about Gobivaz?
Which indications does Gobivaz (ALVO) have EEA approval for?
What formulations of Gobivaz did Alvotech receive approval for in the EEA?
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