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Celltrion Secures the EC’s Approval for Avtozma (Biosimilar, RoActemra)

Shots:Following the US FDA approval, the EC has approved Avtozma (biosimilar, RoActemra) to treat mod. to sev. rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and giant cell arteritis (GCA) Approval was based on the P-III trial of Avtozma (tocilizumab-anoh) vs RoActemra (tocilizumab) in mod. to sev.…

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Celltrion

Celltrion Secures the EC’s Approval for Avtozma (Biosimilar, RoActemra)

Shots:Following the US FDA approval, the EC has approved Avtozma (biosimilar, RoActemra) to treat mod. to sev. rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and giant cell arteritis (GCA) Approval was based on the P-III trial of Avtozma (tocilizumab-anoh) vs RoActemra (tocilizumab) in mod. to sev.…

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Celltrion

Celltrion Secures the US FDA’s Approval for Avtozma IV/SC (Biosimilar, Actemra)

Shots:The US FDA has approved Avtozma IV/SC (biosimilar, Actemra) to treat rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and COVID-19; expected to be commercially available by August 2025 in US Approval was based on the P-III trial of Avtozma (tocilizumab-anoh) vs Actemra (tocilizumab) in…

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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…

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