Advanz Pharma and Alvotech receive European approval for Mynzepli®, Biosimilar to Eylea®
Alvotech (NASDAQ: ALVO) and Advanz Pharma have received European Commission approval for Mynzepli®, a biosimilar to Eylea® (aflibercept), for treating various retinal diseases. The approval covers all European Economic Area countries and follows positive clinical trial results demonstrating therapeutic equivalence to Eylea®.
The biosimilar is approved for treating multiple eye conditions including wet age-related macular degeneration (AMD), macular edema, diabetic macular edema (DME), and myopic choroidal neovascularization. Notably, Eylea® generated global sales of approximately $9 billion in 2024, with one-third from Europe.
Mynzepli® will be available as a 40 mg/mL solution for injection in both pre-filled syringe and vial formats. The approval is currently under review in other major markets, including the United States and Japan.
Alvotech (NASDAQ: ALVO) e Advanz Pharma hanno ottenuto l'approvazione della Commissione Europea per Mynzepli®, un biosimilare di Eylea® (aflibercept) per il trattamento di diverse malattie retiniche. L'autorizzazione riguarda tutti i paesi dello Spazio Economico Europeo ed è arrivata dopo risultati clinici positivi che ne hanno dimostrato l'equivalenza terapeutica con Eylea®.
Il biosimilare è approvato per il trattamento di più patologie oculari, tra cui la degenerazione maculare umida legata all'età (AMD), l'edema maculare, l'edema maculare diabetico (DME) e la neovascolarizzazione coroideale miopica. Per riferimento, Eylea® ha registrato vendite globali di circa 9 miliardi di dollari nel 2024, di cui circa un terzo in Europa.
Mynzepli® sarà disponibile come soluzione iniettabile a 40 mg/mL, sia in siringa pre-riempita sia in fiala. L'approvazione è al momento in valutazione anche in altri mercati importanti, inclusi Stati Uniti e Giappone.
Alvotech (NASDAQ: ALVO) y Advanz Pharma han obtenido la aprobación de la Comisión Europea para Mynzepli®, un biosimilar de Eylea® (aflibercept) para el tratamiento de diversas enfermedades de la retina. La autorización cubre todos los países del Área Económica Europea y se basa en resultados clínicos positivos que demostraron equivalencia terapéutica con Eylea®.
El biosimilar está aprobado para tratar múltiples afecciones oculares, incluidas la degeneración macular húmeda relacionada con la edad (DMAE), el edema macular, el edema macular diabético (DME) y la neovascularización coroidea miópica. Cabe destacar que Eylea® generó ventas globales de aproximadamente 9.000 millones de dólares en 2024, con un tercio procedente de Europa.
Mynzepli® estará disponible como solución para inyección a 40 mg/mL, tanto en jeringa prellenada como en vial. La aprobación se está revisando actualmente en otros mercados importantes, incluidos Estados Unidos y Japón.
Alvotech (NASDAQ: ALVO)와 Advanz Pharma가 망막 질환 치료제인 Mynzepli®(aflibercept의 바이오시밀러)에 대해 유럽연합 집행위원회 승인을 받았습니다. 승인은 유럽 경제 지역 전체를 대상으로 하며, Eylea®와의 치료적 동등성이 입증된 긍정적인 임상 결과를 바탕으로 이뤄졌습니다.
이 바이오시밀러는 습성 연령관련 황반변성(AMD), 황반부종, 당뇨성 황반부종(DME), 근시성 맥락막 신생혈관증 등 여러 안구 질환의 치료에 승인되었습니다. 참고로 Eylea®는 2024년 전 세계에서 약 90억 달러의 매출을 올렸으며 그중 약 3분의 1이 유럽에서 발생했습니다.
Mynzepli®는 40 mg/mL 주사용 액제로, 프리필드 시린지와 바이알 두 가지 제형으로 제공될 예정입니다. 현재 미국과 일본 등 주요 시장에서도 승인 심사가 진행 중입니다.
Alvotech (NASDAQ: ALVO) et Advanz Pharma ont obtenu l'approbation de la Commission européenne pour Mynzepli®, un biosimilaire d'Eylea® (aflibercept), destiné au traitement de diverses maladies rétiniennes. L'autorisation couvre tous les pays de l'Espace économique européen et fait suite à des essais cliniques concluants ayant démontré l'équivalence thérapeutique avec Eylea®.
Le biosimilaire est approuvé pour le traitement de plusieurs affections oculaires, notamment la dégénérescence maculaire liée à l'âge de type humide (DMLA), l'œdème maculaire, l'œdème maculaire diabétique (DME) et la néovascularisation choroïdienne myopique. À titre de référence, Eylea® a généré des ventes mondiales d'environ 9 milliards de dollars en 2024, dont un tiers en Europe.
Mynzepli® sera disponible sous forme de solution injectable à 40 mg/mL, en seringue préremplie et en flacon. L'autorisation est actuellement en cours d'examen dans d'autres marchés majeurs, notamment les États-Unis et le Japon.
Alvotech (NASDAQ: ALVO) und Advanz Pharma haben die Zulassung der Europäischen Kommission für Mynzepli®, einen Biosimilar zu Eylea® (Aflibercept), erhalten. Die Zulassung gilt für alle Länder des Europäischen Wirtschaftsraums und folgt auf positive klinische Studien, die therapeutische Gleichwertigkeit zu Eylea® nachgewiesen haben.
Der Biosimilar ist zur Behandlung mehrerer Augenerkrankungen zugelassen, darunter feuchte altersbedingte Makuladegeneration (AMD), Makulaödem, diabetisches Makulaödem (DME) und myope choroidale Neovaskularisation. Eylea® erzielte weltweit Umsätze von etwa 9 Milliarden US-Dollar im Jahr 2024, ein Drittel davon in Europa.
Mynzepli® wird als 40 mg/mL Injektionslösung sowohl in vorgefüllter Spritze als auch in Durchstechflasche erhältlich sein. Die Zulassung wird derzeit auch in anderen wichtigen Märkten wie den USA und Japan geprüft.
- European Commission approval received for Mynzepli® biosimilar across all EEA countries
- Targets a significant market with Eylea® generating $9 billion in global sales (2024)
- Successful clinical trials demonstrating therapeutic equivalence to Eylea®
- Approved for all adult indications of the reference drug
- Pending regulatory approvals in other major markets including US and Japan
- Will face competition from existing Eylea® market presence
Insights
EU approval of Alvotech's Eylea biosimilar represents significant revenue potential in a $3B European market for retinal disease treatment.
The European Commission's approval of Mynzepli® (aflibercept), Alvotech's biosimilar version of Eylea®, marks a significant milestone for both Alvotech and Advanz Pharma. This approval grants access to a substantial market, as Eylea® generated approximately
The approval is comprehensive, covering all adult indications of the reference biologic, including neovascular (wet) age-related macular degeneration (AMD), macular edema from retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization. This broad approval scope maximizes the product's potential market reach.
What makes this particularly significant is that Mynzepli® will be available in both pre-filled syringe and vial formulations, providing flexibility for healthcare providers. The approval follows positive clinical trial results announced in January 2024, which demonstrated therapeutic equivalence to Eylea®.
For Alvotech, this represents a critical advancement in their biosimilar portfolio strategy, potentially opening access to a third of Eylea's global market. The company's global ambitions are evident with concurrent regulatory reviews underway in other major markets, including the United States and Japan. If approved in these regions, Alvotech would gain access to even larger portions of the global Eylea® market.
The timing is particularly advantageous as healthcare systems worldwide seek cost-effective alternatives to expensive biologics. Biosimilars typically launch at
- Mynzepli® (aflibercept) is approved in all European Economic Area member countries for the treatment of various retinal diseases including neovascular (wet) age-related macular degeneration (AMD)
- Approval is based on comprehensive analytical, non-clinical and clinical similarity data, including a confirmatory efficacy study comparing Mynzepli® with the reference biologic Eylea® in patients with neovascular AMD
REYKJAVIK, ICELAND and LONDON, UK (August 21, 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 Commission has approved Mynzepli® as a biosimilar to Eylea® (aflibercept), in a pre-filled syringe and vial.
"Timely access to effective therapies is essential for individuals affected by retinal diseases. With millions of Europeans impacted, the approval of Mynzepli represents important progress in providing innovative and affordable treatment options. This helps to ensure that patients throughout Europe have improved access to vision-preserving care, regardless of financial or logistical barriers," said Joseph McClellan, Chief Scientific and Technical Officer of Alvotech.
Nick Warwick, Chief Medical Officer of Advanz Pharma, said “The approval of Mynzepli® marks an important milestone in our mission to broaden access to high-quality and affordable medicines for patients across Europe.”
The centralized marketing authorization is valid in all European Economic Area (EEA) countries, including the 27 member states of the European Union, as well as Norway, Iceland and Lichtenstein. In 2024, global sales of Eylea® were about US
Mynzepli® is approved for all adult indications approved for the reference biologic, neovascular (wet) age-related macular degeneration (AMD), or visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), diabetic macular oedema (DME) or myopic choroidal neovascularization (myopic CNV). Mynzepli® will be available as a 40 mg/mL solution for injection in a pre-filled syringe and 40 mg/mL solution for injection in a vial.
In January 2024 Alvotech announced positive top-line results from a confirmatory clinical study with its biosimilar candidate to Eylea®, known as AVT06, comparing the efficacy, safety, and immunogenicity of the proposed biosimilar to Eylea® in patients with neovascular (wet) AMD. The study met its primary endpoint, with results demonstrating therapeutic equivalence between Alvotech’s biosimilar candidate and Eylea® [1]. The European Commission’s decision to issue a marketing authorization came after the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on approving AVT06, as Mynzepli® (aflibercept). Dossiers for AVT06 are currently under review in multiple countries globally, including the United States and Japan.
About Mynzepli® (aflibercept)
Mynzepli® (aflibercept) is a recombinant fusion protein which has now been approved in the European Economic Area as a biosimilar to Eylea® (aflibercept). Aflibercept binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [2].
Sources
[1] Agostini, H. et.al. (2025). A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration. Expert Opinion on Biological Therapy, 1–15. https://doi.org/10.1080/14712598.2025.2519531
[2] Product information
Use of trademarks
Elyea® is a registered trademark of Bayer AG.
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
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. Advanz Pharma’s 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. Advanz Pharma’s 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. Advanz Pharma’s 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 Advanz Pharma’s ambition, we are partnering with biopharma and development companies to bring medicines to patients. We can only achieve this due to Advanz Pharma’s dedicated and highly qualified employees, acting in line with Advanz Pharma’s company values of entrepreneurship, speed, and integrity.
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FAQ
What is Alvotech's Mynzepli® and what was just approved in Europe?
What conditions can Mynzepli® (NASDAQ: ALVO) treat?
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