Sandoz receives European Commission approval for Afqlir® (aflibercept), further strengthening leading biosimilar portfolio
Sandoz has received European Commission approval for Afqlir® (aflibercept), a biosimilar to Eylea®, for treating various retinal diseases including neovascular age-related macular degeneration (nAMD). The treatment will be available as 2 mg vial kit and pre-filled syringe for intravitreal injection, with launch expected in Q4 2025.
nAMD, affecting the central vision zone, is responsible for 90% of severe vision loss in AMD cases. Out of 3.6 million patients with nAMD across major markets, 2.5 million are diagnosed but only 1.7 million receive treatment.
Sandoz ha ricevuto l'approvazione della Commissione Europea per Afqlir® (aflibercept), un biosimilare di Eylea®, per il trattamento di varie patologie retiniche, tra cui la degenerazione maculare senile neovascolare (nAMD). Il trattamento sarà disponibile in forma di kit da fiala da 2 mg e siringa pre-riempita per iniezione intravitreale, con lancio previsto nel quarto trimestre del 2025.
La nAMD, che colpisce la zona della visione centrale, è responsabile del 90% dei casi di grave perdita della vista negli AMD. Su 3,6 milioni di pazienti con nAMD nei principali mercati, 2,5 milioni sono diagnosticati, ma solo 1,7 milioni ricevono trattamento.
Sandoz ha recibido la aprobación de la Comisión Europea para Afqlir® (aflibercept), un biosimilar de Eylea®, para el tratamiento de diversas enfermedades de la retina, incluida la degeneración macular neovascular asociada a la edad (nAMD). El tratamiento estará disponible en un kit de vial de 2 mg y jeringa precargada para inyección intravítrea, con lanzamiento previsto para el cuarto trimestre de 2025.
La nAMD, que afecta la zona de visión central, es responsable del 90% de la pérdida severa de visión en casos de AMD. De los 3,6 millones de pacientes con nAMD en los principales mercados, 2,5 millones están diagnosticados, pero solo 1,7 millones reciben tratamiento.
산도즈는 Afqlir® (aflibercept)에 대한 유럽연합의 승인을 받았으며, 이는 Eylea®의 바이오시밀러로, 여러 망막 질환, 특히 신생혈관 노인성 황반변성(nAMD) 치료에 사용됩니다. 치료는 2 mg 바이알 키트와 미리 채워진 주사기로 유리체 내 주사용으로 제공되며, 2025년 4분기 출시가 예정되어 있습니다.
nAMD는 중앙 시야 영역에 영향을 미치며, AMD 사례에서 심각한 시력 손실의 90%를 차지합니다. 주요 시장에서 nAMD 환자 360만 명 중 250만 명이 진단되었지만, 치료를 받는 것은 170만 명에 불과합니다.
Sandoz a reçu l'approbation de la Commission Européenne pour Afqlir® (aflibercept), un biosimilaire de l'Eylea®, destiné au traitement de diverses maladies rétiniennes, y compris la dégénérescence maculaire néovasculaire liée à l'âge (nAMD). Le traitement sera disponible sous forme de kit de flacon de 2 mg et de seringue préremplie pour injection intravitréenne, avec un lancement prévu au quatrième trimestre 2025.
La nAMD, qui affecte la zone de vision centrale, est responsable de 90 % des cas de perte de vision sévère dans les cas d'AMD. Parmi les 3,6 millions de patients atteints de nAMD sur les principaux marchés, 2,5 millions sont diagnostiqués mais seulement 1,7 million reçoivent un traitement.
Sandoz hat die Genehmigung der Europäischen Kommission für Afqlir® (Aflibercept) erhalten, ein Biosimilar zu Eylea®, zur Behandlung verschiedener Netzhauterkrankungen, einschließlich der neovaskulären altersbedingten Makuladegeneration (nAMD). Die Behandlung wird als 2 mg Fläschchen-Kit und als vorgefüllte Spritze für die intravitrealen Injektionen erhältlich sein, mit einem geplanten Markteintritt im 4. Quartal 2025.
nAMD, das die zentrale Sehzone betrifft, ist verantwortlich für 90% des schweren Sehverlustes bei AMD-Fällen. Von 3,6 Millionen Patienten mit nAMD in den wichtigsten Märkten sind 2,5 Millionen diagnostiziert, aber nur 1,7 Millionen erhalten eine Behandlung.
- European Commission approval received for Afqlir® biosimilar
- Product launch planned for Q4 2025
- Strengthens company's biosimilar portfolio in a significant market segment
- Addresses large untreated patient population (1.7M out of 2.5M diagnosed patients)
- None.
MEDIA RELEASE
- Afqlir® (aflibercept) approved to treat various retinal diseases, including neovascular age-related macular degeneration (nAMD)
- One of several biosimilar value drivers for Sandoz
- Sandoz remains committed to accelerating patient access by strengthening its biosimilar portfolio, reinforcing global and European leadership
Basel, November 15, 2024 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced that the European Commission (EC) has granted marketing authorization for Afqlir® (aflibercept) 2 mg vial kit and pre-filled syringe for intravitreal injection, a biosimilar to reference medicine Eylea®*[1,2]. Afqlir® is indicated to treat various retinal diseases, including neovascular age-related macular degeneration (nAMD), aiming to prevent disease-related blindness.
Afqlir® is one of several biosimilar value drivers for Sandoz and this approval represents a major step in advancing the company’s growth strategy. Launch is expected as of Q4 2025.
Claire D’Abreu-Hayling, Chief Scientific Officer, Sandoz, said: "Vision loss significantly affects daily activities, from work to social interactions. Early and expanded access to effective treatments is essential for patients to maintain and improve their visual acuity. The approval of Afqlir® is a pivotal moment in delivering an affordable and effective treatment option to patients in Europe who are affected by conditions such as nAMD. This milestone underscores our commitment to improving patient outcomes through accessible, high-quality biosimilars."
nAMD is a subtype of AMD, characterized by a vision loss in the central zone, and is a leading cause of vision impairment in patients over 65 years of age.[3] nAMD accounts for approximately 10 to
*Eylea® is a registered trademark of Bayer AG.
About Afqlir® (aflibercept)
The active ingredient in Afqlir® is aflibercept. Aflibercept is a recombinant fusion protein that binds to vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF), inhibiting abnormal vessel growth. Aflibercept is injected into the eye to improve visual acuity and inhibit disease progression. The robust biosimilar development program of Afqlir® consisted of a comprehensive package including analytical and preclinical in vitro study data, as well as clinical data from the Mylight study, and confirmed that Afqlir® has equivalent efficacy and comparable safety to its reference medicine.
Afqlir® is indicated to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (nAMD), macular oedema following retinal vein occlusion (RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (mCNV).[1]
DISCLAIMER
This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law.
REFERENCES
[1] European Medicines Agency (EMA). Afqlir (aflibercept): Prescribing Information. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/afqlir [Last accessed November 2024].
[2] European Medicines Agency (EMA). Eylea (aflibercept): Prescribing Information. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/eylea [Last accessed November 2024].
[3] Galindo-Camacho RM, Blanco-Llamero C, da Ana R, Fuertes MA, Señoráns FJ, Silva AM, García ML, Souto EB. Therapeutic Approaches for Age-Related Macular Degeneration. Int J Mol Sci. 2022 Oct 4;23(19):11769. doi: 10.3390/ijms231911769. PMID: 36233066; PMCID: PMC9570118.
[4] Quillen DA. Am Fam Physician. 1999;60(1):99-108.
[5] DRG Clarivate Landscape & Forecast. Dry and Wet Age-Related Macular Degeneration. November 2020.
ABOUT SANDOZ
Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 800 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2023, Sandoz recorded net sales of USD 9.6 billion.
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