On November 18, 2024, Samsung Bioepis Co., Ltd. and Biogen Inc. announced that the European Commission (EC) granted marketing authorization for OPUVIZ™ (aflibercept biosimilar, also known as SB15). This approval is for the treatment of adult patients with 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 EC approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and was based on a totality 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.
OPUVIZ™ is the second ophthalmology biosimilar and the fifth biosimilar in the portfolio developed by Samsung Bioepis with commercialization rights held by Biogen in Europe. This approval is expected to create a new treatment option for eligible patients and contribute to easing the cost burden associated with these retinal conditions, thereby expanding access to vital biologic therapies across Europe.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.