European Medicines Agency Confirms Acceptance of Marketing Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept)
Alvotech (NASDAQ: ALVO) and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech's proposed biosimilar to Eylea® (aflibercept). The approval process is expected to be completed by Q3 2025. This development marks a significant step towards making AVT06 available in Europe, potentially benefiting patients and caregivers.
Alvotech is responsible for AVT06's development and commercial supply, while Advanz Pharma holds exclusive commercialization rights in Europe, except for France and Germany. In 2023, Eylea® sales in Europe reached $2.9 billion, with global sales totaling $5.9 billion. Alvotech recently reported positive top-line results from a confirmatory clinical study comparing AVT06 with Eylea in patients with neovascular (wet) AMD, demonstrating therapeutic equivalence and comparable safety.
Alvotech (NASDAQ: ALVO) e Advanz Pharma hanno annunciato che l'Agenzia Europea per i Medicinali (EMA) ha accettato una Richiesta di Autorizzazione all'Immissione in Commercio per AVT06, il proposto biosimilare di Alvotech a Eylea® (aflibercept). Si prevede che il processo di approvazione sarà completato entro il Q3 2025. Questo sviluppo rappresenta un passo significativo verso la disponibilità di AVT06 in Europa, potenzialmente a beneficio di pazienti e caregiver.
Alvotech si occupa dello sviluppo e della fornitura commerciale di AVT06, mentre Advanz Pharma detiene i diritti esclusivi di commercializzazione in Europa, ad eccezione di Francia e Germania. Nel 2023, le vendite di Eylea® in Europa hanno raggiunto $2,9 miliardi, con vendite globali totali pari a $5,9 miliardi. Alvotech ha recentemente riportato risultati positivi da uno studio clinico confermatorio che confronta AVT06 con Eylea in pazienti con AMD neovascolare (umida), dimostrando equivalenza terapeutica e sicurezza comparabile.
Alvotech (NASDAQ: ALVO) y Advanz Pharma anunciaron que la Agencia Europea de Medicamentos (EMA) ha aceptado una Solicitud de Autorización de Comercialización para AVT06, el propuesto biosimilar de Alvotech a Eylea® (aflibercept). Se espera que el proceso de aprobación se complete para el Q3 2025. Este desarrollo representa un paso significativo hacia la disponibilidad de AVT06 en Europa, beneficiando potencialmente a pacientes y cuidadores.
Alvotech es responsable del desarrollo y suministro comercial de AVT06, mientras que Advanz Pharma tiene derechos exclusivos de comercialización en Europa, excepto en Francia y Alemania. En 2023, las ventas de Eylea® en Europa alcanzaron $2.9 mil millones, con ventas globales totales de $5.9 mil millones. Alvotech ha informado recientemente resultados positivos de un estudio clínico confirmatorio que compara AVT06 con Eylea en pacientes con AMD neovascular (húmeda), demostrando equivalencia terapéutica y seguridad comparable.
Alvotech (NASDAQ: ALVO)와 Advanz Pharma는 유럽 의약품청(EMA)이 Alvotech의 Eylea® (aflibercept)에 대한 제안된 바이오시밀러인 AVT06에 대한 마케팅 허가 신청을 수락했다고 발표했습니다. 승인 과정은 2025년 3분기까지 완료될 것으로 예상됩니다. 이 발전은 AVT06이 유럽에서 이용 가능하게 되는 중요한 단계로, 환자와 간병인에게 잠재적인 혜택을 줄 수 있습니다.
Alvotech는 AVT06의 개발 및 상업 공급을 담당하며, Advanz Pharma는 프랑스와 독일을 제외한 유럽에서 독점 상업화 권리를 보유하고 있습니다. 2023년 Eylea®의 유럽 매출은 29억 달러에 달했으며, 글로벌 매출 총액은 59억 달러입니다. Alvotech는 최근 AVT06을 Eylea와 비교한 임상 연구에서 긍정적인 최종 결과를 보고하여 치료 등가성과 유사한 안전성을 입증했습니다.
Alvotech (NASDAQ: ALVO) et Advanz Pharma ont annoncé que l'Agence européenne des médicaments (EMA) a accepté une demande d'autorisation de mise sur le marché pour AVT06, le biosimilaire proposé par Alvotech pour Eylea® (aflibercept). Le processus d'approbation devrait être achevé d'ici le Q3 2025. Ce développement marque une étape significative vers la disponibilité d'AVT06 en Europe, bénéficiant potentiellement aux patients et aux aidants.
Alvotech est responsable du développement et de l'approvisionnement commercial d'AVT06, tandis qu'Advanz Pharma détient les droits exclusifs de commercialisation en Europe, à l'exception de la France et de l'Allemagne. En 2023, les ventes d'Eylea® en Europe ont atteint 2,9 milliards de dollars, avec des ventes mondiales totalisant 5,9 milliards de dollars. Alvotech a récemment rapporté des résultats positifs d'une étude clinique de confirmation comparant AVT06 à Eylea chez des patients atteints d'AMD néovasculaire (humide), démontrant une équivalence thérapeutique et une sécurité comparable.
Alvotech (NASDAQ: ALVO) und Advanz Pharma haben bekannt gegeben, dass die Europäische Arzneimittel-Agentur (EMA) einen Antrag auf Marktzulassung für AVT06, das vorgeschlagene Biosimilar von Alvotech zu Eylea® (Aflibercept), akzeptiert hat. Der Genehmigungsprozess soll bis Q3 2025 abgeschlossen sein. Diese Entwicklung stellt einen bedeutenden Schritt in Richtung Verfügbarkeit von AVT06 in Europa dar, was potenziell Patienten und Pflegepersonen zugutekommen kann.
Alvotech ist verantwortlich für die Entwicklung und den kommerziellen Vertrieb von AVT06, während Advanz Pharma in Europa, mit Ausnahme von Frankreich und Deutschland, die exklusiven Vermarktungsrechte hält. Im Jahr 2023 erreichten die Eylea®-Verkäufe in Europa 2,9 Milliarden Dollar, während die globalen Verkäufe insgesamt 5,9 Milliarden Dollar betrugen. Alvotech berichtete kürzlich über positive Ergebnissen einer bestätigenden klinischen Studie, die AVT06 mit Eylea bei Patienten mit neovaskulärer (feuchter) AMD verglich und therapeutische Äquivalenz und vergleichbare Sicherheit nachwies.
- EMA acceptance of Marketing Authorization Application for AVT06, a proposed biosimilar to Eylea®
- Potential market entry in Europe by Q3 2025
- Positive top-line results from confirmatory clinical study showing therapeutic equivalence to Eylea®
- Large market opportunity: Eylea® sales in Europe reached $2.9 billion in 2023
- None.
Insights
The EMA's acceptance of AVT06's marketing application marks a significant milestone for Alvotech and Advanz Pharma. This biosimilar to Eylea® (aflibercept) could potentially disrupt the
The positive results from the confirmatory clinical study, demonstrating therapeutic equivalence and comparable safety to Eylea®, strengthen AVT06's market potential. This development, coupled with Alvotech's pipeline including AVT29 (high-dose biosimilar), positions the company as a strong contender in the ophthalmology biosimilars space. The partnership with Advanz Pharma for European commercialization could accelerate market penetration upon approval.
The potential market entry of AVT06 in Europe by late 2025 could significantly impact the revenue streams of Eylea®'s manufacturer. With Eylea® generating
Alvotech's end-to-end biosimilars platform demonstrates scalability and efficiency in developing multiple candidates, which could lead to improved profit margins and a competitive edge in the burgeoning biosimilars market. The strategic partnerships for commercialization in key European markets may help optimize market penetration and revenue potential upon approval.
The potential introduction of AVT06 in the European market aligns with the broader healthcare policy trend of promoting biosimilars to reduce healthcare costs. As governments and payers seek to manage rising healthcare expenditures, biosimilars like AVT06 could play a important role in expanding access to critical treatments for conditions like wet AMD, macular edema and diabetic retinopathy.
The successful development and potential approval of AVT06 could set a precedent for future ophthalmology biosimilars, potentially accelerating the development and approval processes for similar products. This could lead to a more competitive and cost-effective market for biologic eye treatments, benefiting both healthcare systems and patients across Europe. Investors should consider the long-term implications of this shift in the ophthalmology treatment landscape.
- The approvals process is anticipated to be completed in the third quarter of 2025
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and 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 (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept). The process to obtain marketing authorization could be completed in the third quarter of 2025.
"EMA acceptance takes us a step closer to making AVT06 available in Europe, which is good news for patients and caregivers," said Joseph McClellan, Chief Scientific Officer of Alvotech. "The successful development of multiple biosimilar candidates, demonstrates how Alvotech leverages its end-to-end biosimilars platform in support of broader access to affordable biologic medicines."
Dr. Nick Warwick, Chief Medical Officer for Advanz Pharma, said “This milestone is an important step towards providing patients with more treatment options and further strengthens Advanz Pharma’s commitment to expand access to specialty, hospital, and rare disease medicines across Europe.”
Alvotech is responsible for development and commercial supply of AVT06. Advanz Pharma is responsible for registration and has exclusive commercialization rights in Europe, except for France and Germany where the rights are semi-exclusive. French pharmaceutical company Biogaran holds semi-exclusive registration and commercialization rights for France. Alvotech is also developing AVT29, a biosimilar candidate for Eylea® high dose (8 mg). Advanz Pharma and Biogaran will also commercialize AVT29, for the same countries as AVT06.
Eylea® is a widely used biologic for the treatment of eye disorders, including diseases which can lead to vision loss or blindness, such as wet Age-related Macular Degeneration (AMD), macular edema, and diabetic retinopathy. In 2023, reported sales of Eylea® in Europe were
In January 2024, Alvotech announced positive top-line results from a confirmatory clinical study (AVT06-GL-C01) comparing the efficacy, safety, and immunogenicity of AVT06 with Eylea in patients with neovascular (wet) AMD. The study met its primary endpoint, with results demonstrating therapeutic equivalence and comparable safety including immunogenicity between Alvotech’s biosimilar candidate and Eylea.
About AVT06/AVT29 (aflibercept)
AVT06/AVT29 is a recombinant fusion protein and a biosimilar candidate to Eylea® (aflibercept) 2 mg and 8 mg dose, which binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [2]. AVT06/AVT29 are investigational products and have not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
Sources
[1] Regeneron Full Year 2023 Earnings Press Release
[2] Eylea product information
Use of trademarks
Elyea is a registered trademark of Regeneron Pharmaceuticals Inc. and 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 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 (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 www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
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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, specialty generics & biosimilars, and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, 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.
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CONTACTS
ALVOTECH
Benedikt Stefansson, VP Investor Relations and Global Communications
alvotech.ir@alvotech.com
ADVANZ PHARMA
Courtney Baines
Tel: +44 7776 516979
courtney.baines@advanzpharma.com
FAQ
What is the current status of Alvotech's AVT06 biosimilar for Eylea® in Europe?
What were Eylea®'s sales figures in Europe and globally for 2023?
What were the results of Alvotech's clinical study for AVT06 (ALVO)?
Who will be responsible for commercializing AVT06 in Europe?
