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Celltrion
NEWS

Celltrion’s Eydenzelt (Biosimilar, Eylea) Receives Health Canada Approval to Treat Multiple Retinal Diseases

Shots: Health Canada has approved Eydenzelt, a biosimilar version of Eylea (aflibercept 2mg), in both vial & PFS presentation for all the indications of the reference product Approval was based on extensive analytical, nonclinical, & clinical data, incl. a global 52wk. P-III trial of Eydenzelt vs Eylea in 348 pts with diabetic macular edema, which met…
5 days ago

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Celltrion
NEWS

Celltrion’s Eydenzelt (Biosimilar, Eylea) Receives the US FDA’s Approval to Treat Multiple Retinal Diseases

Shots: The US FDA has approved Eydenzelt, a biosimilar version of Eylea (aflibercept), to treat neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema (DME), & diabetic retinopathy Approval was supported by extensive analytical, non-clinical, & clinical data, incl. a P-III trial in DME pts (n=348) comparing Eydenzelt vs Eylea over…
October 10, 2025

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Celltrion
NEWS

Celltrion Secures the EC’s Approval for Eydenzelt (Biosimilar, Eylea), Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

Shots: The EC has approved Eydenzelt (CT-P42, aflibercept), a biosimilar to Eylea, Stoboclo & Osenvelt (CT-P41, denosumab), a biosimilar to Prolia & Xgeva for all indications of the reference products The P-III trial of Eydenzelt (40 mg/mL solution for injection in a vial & pre-filled syringe) vs Eylea (aflibercept) in diabetic macular edema (DME)…
February 19, 2025

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Celltrion
NEWS

Celltrion Secures the CHMP’s Positive Opinion for Eydenzelt (Biosimilar, Eylea), Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva) and Avtozma (Biosimilar, RoActemra)

Shots:  The P-III trial of Eydenzelt vs Eylea (aflibercept) in diabetic macular edema (DME) patients achieved its 1EP of BCVA improvement at wk.8, demonstrating equivalent efficacy, safety & immunogenicity  The P-III study of Stoboclo & Osenvelt vs Prolia & Xgeva (denosumab) in patients (n=479) achieved its 1EP, showing equivalent efficacy in lumbar spine bone mineral…
December 16, 2024

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Celltrion
NEWS

Celltrion Secures the CHMP’s Positive Opinion for Eydenzelt (Biosimilar, Eylea), Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva) and Avtozma (Biosimilar, RoActemra) 

Shots:  The P-III trial of Eydenzelt vs Eylea (aflibercept) in diabetic macular edema (DME) patients achieved its 1EP of BCVA improvement at wk.8, demonstrating equivalent efficacy, safety & immunogenicity  The P-III study of Stoboclo & Osenvelt vs Prolia & Xgeva (denosumab) in patients (n=479) achieved its 1EP, showing equivalent efficacy in lumbar spine bone mineral…
December 16, 2024

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