Positive CHMP opinion for Aflibercept Biosimilar
Samsung Bioepis Co., Ltd. and Biogen Inc. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Opuviz 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea (aflibercept), also known as SB15.
Opuviz has been recommended for approval in adult patients for the treatment of neovascular (wet) age related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV).
The CHMP’s positive opinion was based on a totality of evidence including analytical, non-clinical data, and clinical data. A randomized, double-masked, parallel group, multicenter Phase 3 study demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics (PK) profiles between SB15 and reference aflibercept (AFL). The primary endpoint was met in terms of change from baseline in best corrected visual acuity (BCVA) at week 8, and the 32-week interim analysis and 56-week analysis demonstrated comparability in other secondary efficacy, safety, immunogenicity, and PK endpoints between SB15 and AFL.
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