UK High Court Rules in Favor of Alvotech Paving Way for Manufacture and Market Entry of AVT06, biosimilar to Eylea® (aflibercept)
Alvotech (NASDAQ: ALVO) won expedited UK High Court proceedings brought by Regeneron and Bayer, which rejected requests for an injunction blocking manufacturing at Alvotech’s UK CMO for its biosimilar AVT06 (aflibercept), a biosimilar to Eylea.
The decision permits Alvotech to continue manufacture and storage of AVT06 in the UK for distribution in the UK, EEA and other countries and supports commercial launches after the expiry of Eylea Supplementary Protection Certificates on November 23, 2025. AVT06 received European Commission approval on August 21, 2025 and MHRA approval on August 28, 2025.
Alvotech (NASDAQ: ALVO) ha ottenuto procedimenti accelerati presso la High Court del Regno Unito avviati da Regeneron e Bayer, che hanno respinto le richieste di un'ingiunzione finalizzate a bloccare la produzione presso il CMO britannico di Alvotech per il biosimilare AVT06 (aflibercept), un biosimilare di Eylea.
La decisione consente ad Alvotech di continuare la produzione e lo stoccaggio di AVT06 nel Regno Unito per la distribuzione nel Regno Unito, nello Spazio Economico Europeo e in altri Paesi e sostiene i lanci commerciali dopo la scadenza delle Supplementary Protection Certificates di Eylea il 23 novembre 2025. AVT06 ha ottenuto l'approvazione della Commissione Europea il 21 agosto 2025 e l'approvazione MHRA il 28 agosto 2025.
Alvotech (NASDAQ: ALVO) ganó un procedimiento expedito ante la High Court del Reino Unido iniciado por Regeneron y Bayer, que rechazaron las solicitudes de una orden de bloqueo de la fabricación en el CMO británico de Alvotech para su biosimilar AVT06 (aflibercept), un biosimilar de Eylea.
La decisión permite a Alvotech continuar con la fabricación y el almacenamiento de AVT06 en el Reino Unido para distribución en el Reino Unido, el EEE y otros países y respalda los lanzamientos comerciales tras la expiración de los Certificados de Protección Suplementaria de Eylea el 23 de noviembre de 2025. AVT06 recibió la aprobación de la Comisión Europea el 21 de agosto de 2025 y la aprobación de la MHRA el 28 de agosto de 2025.
Alvotech (NASDAQ: ALVO)는 Regeneron과 Bayer가 제기한 영국 고등법원(High Court) 신속 절차에서 승소했으며, AVT06 (아플리버셉트), Eylea의 바이오시밀러의 제조를 차단하는 금지 명령 요청을 기각했다.
이 결정은 알보텍이 영국 내 CMO에서 AVT06의 제조 및 보관을 영국, EEA 및 기타 국가로의 배포를 위해 계속할 수 있도록 하며, Eylea 보조 보호증서의 만료일인 2025년 11월 23일 이후의 상업적 출시를 지지한다. AVT06은 2025년 8월 21일에 유럽 집행위원회 승인을, 2025년 8월 28일에 MHRA 승인를 받았다.
Alvotech (NASDAQ: ALVO) a remporté une procédure accélérée devant la Haute Cour du Royaume-Uni engagée par Regeneron et Bayer, qui avaient rejeté les demandes d'injonction bloquant la fabrication chez le CMO britannique d'Alvotech pour son biosimilaire AVT06 (aflibercept), un biosimilaire d'Eylea.
La décision permet à Alvotech de poursuivre la fabrication et le stockage de AVT06 au Royaume-Uni pour la distribution au Royaume-Uni, dans l’EEE et dans d’autres pays et soutient les lancements commerciaux après l’expiration des certificats de protection complémentaires d’Eylea le 23 novembre 2025. AVT06 a reçu l’approbation de la Commission européenne le 21 août 2025 et l’approbation de la MHRA le 28 août 2025.
Alvotech (NASDAQ: ALVO) gewann ein beschleunigtes Verfahren vor dem britischen High Court, das von Regeneron und Bayer eingeleitet wurde, und wies Anträge auf eine einstweilige Verfügung zurück, die die Herstellung beim britischen CMO von AVT06 (Aflibercept), dem Biosimilar zu Eylea, blockieren sollten.
Die Entscheidung erlaubt es Alvotech, die Herstellung und Lagerung von AVT06 im Vereinigten Königreich für die Verteilung im Vereinigten Königreich, im EWR und in anderen Ländern fortzusetzen und unterstützt kommerzielle Markteinführungen nach Ablauf der Supplementary Protection Certificates von Eylea am 23. November 2025. AVT06 erhielt die Genehmigung der Europäischen Kommission am 21. August 2025 und die MHRA-Zulassung am 28. August 2025.
ألفوتيك (المُدرجة في ناسداك: ALVO) فازت في إجراءات سريعة أمام المحكمة العليا في المملكة المتحدة التي رفعها Regeneron وBayer، والتي رفضت طلبات أمر قضائي يمنع التصنيع في CMO البريطاني لمنتجها البيوسي-مشابه AVT06 (أفليبرسِبْت)، وهو بيوسيـميلـر لـ Eylea.
القرار يسمح لـ Alvotech بالاستمرار في التصنيع وتخزين AVT06 في المملكة المتحدة للتوزيع في المملكة المتحدة وEEA ودول أخرى ويدعم الإطلاقات التجارية بعد انتهاء شهادات الحماية التكميليّة لـ Eylea في 23 نوفمبر 2025. حصل AVT06 على موافقة المفوضية الأوروبية في 21 أغسطس 2025 وعلى موافقة MHRA في 28 أغسطس 2025.
- UK High Court denied injunction on manufacturing at UK CMO
- SPC expiry date set at November 23, 2025
- European Commission approved AVT06 on August 21, 2025
- MHRA approved AVT06 on August 28, 2025
- Decision enables stockpiling and launches in UK, EEA and export markets
- Legal challenge by Regeneron and Bayer created launch uncertainty until November 10, 2025
Insights
UK High Court rejected injunction, enabling UK manufacturing and stockpiling of AVT06 ahead of SPC expiry.
In simple terms, the court found the SPC waiver applies to third‑party manufacturing here, allowing **Alvotech** and its UK CMO to continue making and storing the biosimilar AVT06. This clears a legal barrier tied to
The ruling reduces the immediate regulatory/legal risk of injunctions that would block production and inventory build‑up. Remaining legal dependencies include any appeal by **Regeneron** or **Bayer** and compliance with national release/import rules; these are standard procedural risks and not new factual obstacles in the announcement. Watch for any filed appeals and final court orders over the next weeks to months.
Decision enables scheduled commercial manufacturing and regional launch preparation for AVT06.
Operationally, the verdict permits continued production and warehousing of AVT06 in the UK for later distribution to the UK, EEA and other markets, supporting launch readiness after SPC expiry. That preserves supply‑chain timing and the ability to meet initial market demand without delay from injunctions.
Key near‑term items to monitor are logistic clearances, release testing and the timing around the
REYKJAVIK, ICELAND (November 10, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today the outcome of expedited infringement proceedings before the UK High Court by Regeneron Pharmaceuticals Inc. (“Regeneron”) and Bayer AG (“Bayer”) against Alvotech and its contract manufacturing organization (CMO) in the United Kingdom. The court rejected Regeneron’s and Bayer’s injunction request in relation to manufacturing activities at Alvotech’s CMO in the UK for Alvotech’s biosimilar to Eylea® (AVT06). The decision will support commercial launches of Alvotech’s biosimilar in the European Economic Area, the UK and other countries after the expiry date for Supplementary Protection Certificates (SPCs) for Eylea®, which is November 23, 2025.
“The outcome of this case was never in doubt in my mind, but we are of course very pleased to have obtained this decision by the UK High Court. This will allow Alvotech to proceed with its manufacturing activities and supports bringing our biosimilar to Eylea to patients and caregivers in Europe and the rest of the world,” said Robert Wessman chairman and CEO of Alvotech. “It took years to put an SPC waiver system in place, and it is very important for European biosimilars manufacturers that the waiver system is functional and not abused. An important objective is to bring biosimilars production and jobs back into Europe. This decision by the UK High Court is therefore not only a victory for Alvotech and its partners, but also for patients and caregivers in Europe and in the rest of the world who need better access to quality biologics.”
The case focused on the issue of an SPC waiver exempting certain acts of third-party manufacturers from infringement. The SPC regulation provides that SPCs should not block manufacturing of biosimilars for stockpiling during six months before the SPC expiry, in support of product launches in the European Economic Area and the UK, as well as export to countries outside this region during the lifetime of the SPC. The decision of the UK High Court means that Alvotech and its CMO can continue to manufacture and store AVT06 in the UK, for later distribution in the UK, EEA and rest of the world.
Alvotech announced on August 21, 2025, that the European Commission had approved AVT06 as a biosimilar to Eylea®, for marketing in the European Economic Area. The UK Medicines and Healthcare products Regulatory Agency (MHRA) approved AVT06 for marketing in the UK on August 28, 2025.
About AVT06 (aflibercept)
AVT06 (aflibercept) is a recombinant fusion protein and has been approved in Japan, the United Kingdom and the European Economic Area as a biosimilar to Eylea® (aflibercept), which binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [1]. Dossiers for AVT06, are currently under review in multiple countries globally, including the United States.
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. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. 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 (EEA, UK and US), Biogaran (FR), 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 https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
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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.
ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS
Benedikt Stefansson, VP
alvotech.ir@alvotech.com
FAQ
What did the UK High Court decide about Alvotech (ALVO) and AVT06 on November 10, 2025?
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