European Medicines Agency Recommends Marketing Approval of Gobivaz®, Alvotech’s Proposed Biosimilar to Simponi® (golimumab) with Advanz Pharma as Commercialization Partner
Alvotech (NASDAQ: ALVO) and Advanz Pharma have announced that the European Medicines Agency's CHMP has recommended marketing approval for Gobivaz®, a proposed biosimilar to Simponi® (golimumab). The biosimilar is intended for treating several chronic inflammatory diseases.
The recommendation covers 50 mg/0.5mL and 100mg/mL dosages in pre-filled syringe and autoinjector forms. The treatment is indicated for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis in adults and juvenile idiopathic arthritis across the EU, Norway, Iceland, and Lichtenstein.
The recommendation follows successful clinical trials, including positive top-line results from a confirmatory study in April 2024 and a pharmacokinetic study in November 2023.
Alvotech (NASDAQ: ALVO) e Advanz Pharma hanno annunciato che il CHMP dell'Agenzia Europea per i Medicinali (EMA) ha raccomandato l'autorizzazione all'immissione in commercio per Gobivaz®, un biosimilare proposto di Simponi® (golimumab). Il biosimilare è destinato a trattare diverse malattie infiammatorie croniche.
La raccomandazione riguarda le dosi 50 mg/0,5 mL e 100 mg/mL in formulazioni preriempite e autoiniettori. Il trattamento è indicato per artrite reumatoide, artrite psoriasica, spondilite anchilosante, colite ulcerosa negli adulti e per l'artrite idiopatica giovanile in tutta l'UE, Norvegia, Islanda e Liechtenstein.
La raccomandazione segue trial clinici di successo, inclusi i positivi risultati di topline di uno studio di conferma pubblicati nell'aprile 2024 e uno studio farmacocinetico nel novembre 2023.
Alvotech (NASDAQ: ALVO) y Advanz Pharma han anunciado que el CHMP de la Agencia Europea de Medicamentos ha recomendado la aprobación de comercialización de Gobivaz®, un biosimilar propuesto de Simponi® (golimumab). El biosimilar está destinado a tratar varias enfermedades inflamatorias crónicas.
La recomendación abarca dosis de 50 mg/0,5 mL y 100 mg/mL en formas de jeringa precargada y autoinyector. El tratamiento está indicado para artritis reumatoide, artritis psoriásica, espondiloartritis anquilosante y colitis ulcerosa en adultos y para la artritis idiopática juvenil en la UE, Noruega, Islandia y Liechtenstein.
La recomendación se basa en ensayos clínicos exitosos, incluyendo resultados positivos de topline de un estudio de confirmación en abril de 2024 y un estudio farmacocinético en noviembre de 2023.
알보텍(NASDAQ: ALVO)과 Advanz Pharma가 발표했습니다. 유럽 의약품청(EMA)의 CHMP가 Gobivaz®의 시판 승인을 권고했으며, 이는 Simponi®(골리무맙)의 바이오시밀러로 제시됩니다. 이 바이오시밀러는 여러 만성 염증성 질환의 치료를 목적으로 합니다.
권고 내용은 프리필드 주사기 및 자동주사기 형태의 50 mg/0,5 mL 및 100 mg/mL 용량을 포함합니다. 이 치료는 성인 및 소아 기저의 관절염, 건선 관절염, 강직 척추염, 궤양성 대장염에 대해 EU, 노르웨이, 아이슬란드, 리히텐슈타인에서 적응증으로 사용됩니다.
권고는 2024년 4월의 확정 연구의 양호한 상위 결과와 2023년 11월의 약동학 연구를 포함한 성공적인 임상시험에 따른 것입니다.
Alvotech (NASDAQ: ALVO) et Advanz Pharma ont annoncé que le CHMP de l’Agence européenne des médicaments a recommandé l’autorisation de mise sur le marché pour Gobivaz®, un biosimilaire proposé du Simponi® (golimumab). Le biosimilaire est destiné au traitement de plusieurs maladies inflammatoires chroniques.
La recommandation couvre les doses 50 mg/0,5 mL et 100 mg/mL sous forme de seringues pré-remplies et d’autoinjecteurs. Le traitement est indiqué pour l’arthrite rhumatoïde, l’arthrite psoriasique, la spondylarthrite ankylosante et la colite ulcéreuse chez l’adulte et l’arthrite idiopathique juvénile dans l’UE, la Norvège, l’Islande et le Liechtenstein.
La recommandation fait suite à des essais cliniques réussis, y compris des résultats positifs de topline d’une étude de confirmation en avril 2024 et d’une étude pharmacocinétiques en novembre 2023.
Alvotech (NASDAQ: ALVO) und Advanz Pharma haben bekannt gegeben, dass der CHMP der Europäischen Arzneimittelbehörde eine Marketingfreigabe für Gobivaz® empfohlen hat, ein vorgeschlagenes Biosimilar zu Simponi® (Golimumab). Das Biosimilar soll zur Behandlung mehrerer chronischer entzündlicher Erkrankungen verwendet werden.
Die Empfehlung deckt Dosierungen von 50 mg/0,5 mL und 100 mg/mL in vorkonfektionierten Spritzen- und Autoinjektorformen ab. Die Behandlung ist bei Erwachsenen und juveniler idiopathischer Arthritis für rheumatoide Arthritis, Psoriasis-Arthritis, Spondylitis ankylosans und Colitis ulcerosa vorgesehen, in der EU, Norwegen, Island und Liechtenstein.
Die Empfehlung folgt erfolgreichen klinischen Studien, einschließlich positiver Topline-Ergebnisse einer bestätigenden Studie im April 2024 und einer pharmakokinetischen Studie im November 2023.
Alvotech (NASDAQ: ALVO) و Advanz Pharma أعلنتا أن لجنة CHMP التابعة لهيئة EMA أقرت التوصية بمنح Gobivaz® موافقة التسويق، وهو بيولوجي مشابه مقترح لـ Simponi® (golimumab). يُقصد من البيوسيميلر استخدامه لعلاج عدة أمراض التهابية مزمنة.
التوصية تغطي جرعات 50 mg/0,5 mL و100 mg/mL في أشكال حقن مسبقة التعبئة ومسدس حقن تلقائي. العلاج مخصص لـ ;التهاب المفاصل الروماتويدي، التهاب المفاصل الصدفي، الاستعراض المفصلي القطني، والتهاب القولون التقرحي البالغين، وألفة التهاب المفاصل لدى الأطفال مجهول السبب عبر الاتحاد الأوروبي والنرويج وآيسلندا وليختنشتاين.
تُبنى التوصية على تجارب سريرية ناجحة، بما في ذلك نتائج رئيسية إيجابية من دراسة تأكيدية في أبريل 2024 ودراسة حركية دوائية في نوفمبر 2023.
Alvotech (纳斯达克代码：ALVO) 与 Advanz Pharma 公布，欧洲药品管理局（EMA）的 CHMP 已推荐 Gobivaz® 的上市许可，这是对 Simponi®（golimumab）的拟议生物类似药。该生物类似药旨在治疗多种慢性炎症性疾病。
该建议涵盖以 50 mg/0,5 mL 和 100 mg/mL 的剂量，在预装注射器和自注射器形式。治疗适用于成人及青少年特发性关节炎的类风湿性关节炎、银屑病性关节炎、强直性脊柱炎、溃疡性结肠炎，在欧盟、挪威、冰岛和列支敦士登。
该建议基于包括2024年4月的一项确认性研究的积极 topline 结果以及2023年11月的一项药代动力学研究在内的成功临床试验。
- Positive CHMP recommendation for marketing approval in Europe
- Successful completion of confirmatory clinical studies with positive results
- Broad indication coverage for multiple inflammatory diseases
- Strategic partnership with Advanz Pharma for European commercialization
- None.
Insights
Positive CHMP opinion for Alvotech's golimumab biosimilar signals imminent EU approval, expanding their biosimilar portfolio and European market presence.
The CHMP's positive recommendation for Gobivaz® represents a significant regulatory milestone for Alvotech and its commercialization partner Advanz Pharma. This biosimilar to Janssen's Simponi® (golimumab) has successfully demonstrated comparable efficacy, safety, and immunogenicity profiles through two clinical studies – a confirmatory efficacy trial in rheumatoid arthritis patients and a pharmacokinetic study in healthy volunteers.
The recommendation covers both formulations (50 mg/0.5mL and 100mg/mL) and multiple delivery devices (pre-filled syringe and autoinjector), along with five therapeutic indications: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and juvenile idiopathic arthritis. This broad label approval path mirrors the reference product's approved uses.
While CHMP opinions aren't final authorizations, they typically lead to European Commission approval within 67 days. This partnership leverages Alvotech's development and manufacturing capabilities with Advanz Pharma's European commercialization expertise, reflecting a strategic division of responsibilities that's common in biosimilar business models.
For context, golimumab is a TNF-alpha inhibitor, a class of biologics used to treat inflammatory conditions by suppressing immune response. This recommendation positions Alvotech to potentially capture market share in Europe's anti-TNF market, which represents one of the largest segments in biologic therapies for autoimmune diseases.
REYKJAVIK, ICELAND and LONDON, UK (September 22, 2025) — 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 Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion recommending approval for Gobivaz®, Alvotech’s proposed biosimilar to Simponi® (golimumab), a biologic used to treat several chronic inflammatory diseases.
"We look forward to working with Advanz Pharma to increase access for patients and healthcare professionals to golimumab, as the reference biologic Simponi® is an important treatment option for a number of immune-mediated diseases,” said Joseph McClellan, Chief Scientific and Technical Officer for Alvotech.
“The positive CHMP opinion for Gobivaz® is an important milestone in expanding patient access and marks a significant step forward in Advanz Pharma’s ambition to build a leading biosimilars presence in Europe.” said Nick Warwick, Chief Medical Officer, Advanz Pharma.
The CHMP opinion recommends granting of a marketing authorization for Gobivaz® 50 mg/0.5mL and 100mg/mL in a pre-filled syringe and autoinjector, for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis in adult patients and juvenile idiopathic arthritis across the 27 member states of the European Union, in addition to Norway, Iceland and Lichtenstein.
Gobivaz® remains under EMA regulatory review with a final decision by the European Commission pending.
Alvotech is responsible for the development and commercial supply of Gobivaz®. Advanz Pharma is responsible for registration and has exclusive rights for commercialization in Europe.
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 Simponi® (golimumab) in patients with moderate to severe rheumatoid arthritis. 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.
About AVT05
AVT05 is a biosimilar candidate for Simponi® (golimumab) and Simponi Aria® (golimumab). 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, psoriatic arthritis, and ankylosing spondylitis [1]. AVT05 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
Sources
[1] Simponi product information
Use of trademarks
Simponi® and Simponi Aria® are registered trademarks of Johnson & Johnson.
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 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), 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 generally relate to future events or the future financial or operating performance of Alvotech and may include, for example, Alvotech’s expectations regarding future growth, results of operations, performance, future capital and other expenditures, competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory review and interactions, the satisfactory responses to the FDA’s inspection findings and resolution of other deficiencies conveyed following the re-inspection of Alvotech’s manufacturing site, the potential approval, including for AVT05, and the product candidates in scope of the partnership with Advanz, by the FDA and other regulatory agencies and commercial launch of its product candidates, the timing of the announcement of clinical study results, the commencement of patient studies, regulatory applications, approvals and market launches, and the estimated size of the total addressable market of Alvotech’s pipeline products. 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Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the ability to reach development milestones under commercial partnership agreements including the partnership with Advanz; (2) the ability to raise substantial additional funding, which may not be available on acceptable terms or at all; (3) the ability to maintain stock exchange listing; (4) changes in applicable laws or regulations; (5) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (6) Alvotech’s estimates of expenses and profitability; (7) Alvotech’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (8) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (10) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (11) the ability of Alvotech or its partners, including Advanz, to gain approval from regulators for planned clinical studies, study plans or sites; (12) the ability of Alvotech’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (13) Alvotech’s ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (14) the success of Alvotech’s current and future collaborations, joint ventures, partnerships or licensing arrangements, including the partnership with Advanz; (15) Alvotech’s ability, and that of its commercial partners, including Advanz, to execute their commercialization strategy for approved products; (16) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (17) the outcome of ongoing and future litigation regarding Alvotech’s products and product candidates; (18) the potential impact of the ongoing COVID-19 pandemic on the FDA’s review timelines, including its ability to complete timely inspection of manufacturing sites; (19) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, war in Ukraine and global geopolitical tension, on Alvotech’s business, financial position, strategy and anticipated milestones; and (20) other risks and uncertainties 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. 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MEDIA CONTACTS
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FAQ
What is the significance of EMA's CHMP recommendation for Alvotech's Gobivaz®?
What medical conditions will Alvotech's Gobivaz® treat?
What dosage forms of Gobivaz® (ALVO) are included in the CHMP recommendation?
What clinical evidence supports Alvotech's Gobivaz® approval?
What is the partnership structure between Alvotech and Advanz Pharma for Gobivaz®?
