EU Approves Eydenzelt and Stoboclo Biosimilars
Celltrion announced that the European Commission (EC) has granted marketing authorization for three products across two biosimilars: Eydenzelt (CT-P42, aflibercept), a biosimilar to Eylea to treat multiple retinal disorders, including neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO, branch RVO or central RVO), diabetic macular edema (DME) and myopic choroidal neovascularisation (myopic CNV); and Stoboclo and Osenvelt (CT-P41, denosumab), biosimilars referencing Prolia and Xgeva used for all indications of the reference products
The EC approval expands Celltrion’s diverse biosimilars portfolio across multiple therapeutic areas such as skeletal-related disorders and ophthalmology.
Eydenzelt will be available as 40 mg/ml solution for injection in pre-filled syringe and vial. The active substance of Eydenzelt is aflibercept, an anti neovascularisation agent (ATC code: S01LA05). Aflibercept is a recombinant fusion protein consisting of the extracellular domains of human VEGF receptor 1 and 2 fused to the Fc portion of human IgG1. By acting as a soluble decoy for the natural VEGF receptors, aflibercept inhibits their activation, thereby reducing angiogenesis. Eydenzelt is a biosimilar medicinal product. It is highly similar to the reference product Eylea (aflibercept), which was authorised in the EU on 22 November 2012. Data show that Eydenzelt has comparable quality, safety and efficacy to Eylea.
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