EMA Panel Recommends Aflibercept Biosimilar Eydenzelt for Retinal Disorders
核心洞察
The EMA's CHMP has issued a positive opinion for Celltrion's Eydenzelt, a biosimilar to aflibercept (Eylea), for treating retinal disorders.
Eydenzelt is recommended for neovascular AMD (搜索), diabetic macular edema (搜索), macular edema (搜索) following retinal vein occlusion (搜索) and myopic choroidal neovascularisation (搜索).
A Phase III study demonstrated Eydenzelt's therapeutic equivalence to aflibercept, with similar efficacy, safety, pharmacokinetics, and immunogenicity in DME (搜索) patients.
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Eydenzelt, a biosimilar of aflibercept (Eylea), developed by Celltrion. This decision paves the way for a more affordable treatment option for several retinal disorders, potentially improving access for patients across Europe.
Eydenzelt (CT-P42), a 40 mg/mL solution for injection, is proposed for treating neovascular (wet) age-related macular degeneration (搜索) (AMD (搜索)), diabetic macular edema (搜索) (DME (搜索)), macular edema (搜索) following retinal vein occlusion (搜索) (branch RVO (搜索) or central RVO), and myopic choroidal neovascularisation (搜索) (myopic CNV (搜索)). These conditions are major causes of vision loss worldwide, with AMD affecting millions of elderly individuals and DME being a significant complication of diabetes.
The CHMP's positive opinion is based on a Phase III study that compared Eydenzelt to the reference product, aflibercept, in patients with diabetic macular edema (搜索) (DME (搜索)). The study met predefined equivalence criteria, demonstrating similar efficacy, safety, pharmacokinetics, and immunogenicity profiles between the biosimilar and the original drug.
Taehun Ha, Vice President of Celltrion and Head of the European Business Unit, stated that these approvals highlight Celltrion's dedication to bolstering European healthcare systems by offering affordable, high-quality treatments. The company aims to empower clinicians with the necessary tools and solutions, transitioning from a pioneer to a leader in European healthcare.
The European Commission will now review the CHMP's recommendation and decide whether to grant marketing authorization for Eydenzelt. If approved, Eydenzelt will join other aflibercept biosimilars already authorized in Europe, including Afqlir (Sandoz Group), FYB203 (Formycon AG and Klinge Biopharma GmbH), and OPUVIZ (Samsung Bioepis).
The introduction of aflibercept biosimilars is expected to lower treatment costs and increase patient access to these essential medications. Aflibercept, a VEGF (搜索) inhibitor, has become a standard of care for various retinal vascular diseases, significantly improving visual outcomes for many patients. The availability of biosimilars will further expand treatment options and potentially alleviate the burden on healthcare systems.