On September 20, 2024, Samsung Bioepis and Biogen Inc. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for OPUVIZ™ (aflibercept biosimilar, also known as SB15). This recommendation is for the approval of OPUVIZ™ 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), 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 comprehensive body of evidence, including analytical, non-clinical, and clinical data. A randomized, double-masked, parallel-group, multicenter Phase 3 study demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetic profiles between SB15 and reference aflibercept. The primary endpoint, change from baseline in best corrected visual acuity at week 8, was met, and subsequent analyses through 56 weeks confirmed comparability.
This positive recommendation is a significant milestone for Biogen, as OPUVIZ™ is poised to become the second ophthalmology biosimilar and the fifth biosimilar overall in the portfolio developed by Samsung Bioepis with commercialization rights held by Biogen in Europe. The European Commission is expected to make a final decision on the marketing authorization for OPUVIZ™, which could broaden access to essential treatments and offer substantial healthcare savings for patients with retinal disorders.
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