European Commission Approves Samsung Bioepis' Aflibercept Biosimilar, OPUVIZ
Key Insights
The European Commission has approved OPUVIZ, Samsung Bioepis (search)' biosimilar referencing aflibercept (Eylea), for treating several retinal disorders.
OPUVIZ is indicated for neovascular age-related macular degeneration, macular edema (search) secondary to retinal vein occlusion (search), diabetic macular edema (search), and myopic choroidal neovascularization (search).
A Phase 3 study demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics between OPUVIZ (SB15) and reference aflibercept.
The European Commission (EC) has granted approval to OPUVIZ (aflibercept) 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea (aflibercept), developed and registered by Samsung Bioepis (search). This approval marks a significant step towards providing a more accessible treatment option for various retinal disorders.
OPUVIZ is now approved for use in adult patients for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular edema (search) secondary to retinal vein occlusion (search) (RVO; branch or central RVO), visual impairment due to diabetic macular edema (search) (DME), and visual impairment due to myopic choroidal neovascularization (search) (myopic CNV).
Impact on Patient Access
Byoungin Jung, Vice President, Regulatory Affairs at Samsung Bioepis (search), highlighted the importance of this approval, stating, "Retinal disorders are affecting millions of people’s lives in Europe, yet many patients face barriers to treatment due to high costs. The EC approval for OPUVIZ represents a major step toward our goal of expanding access to vital biologic therapies for those in need."
Wolfram Schmidt, Head of Europe at Biogen, a collaborating company, added, "This approval is an exciting milestone for both patients and healthcare systems in Europe. OPUVIZ has the potential to create a new treatment option for eligible patients, while also easing the burden of costs associated with these retinal conditions."
Clinical Trial Data
The EC approval was based on a comprehensive review of analytical, non-clinical, and clinical data, including a Phase 3 study. This randomized, double-masked, parallel-group, multicenter study demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics (PK) profiles between SB15 (OPUVIZ) and reference aflibercept. The primary endpoint, change from baseline in best-corrected visual acuity (BCVA) at week 8, was met. Interim analysis at 32 weeks and a full analysis at 56 weeks confirmed comparability in secondary efficacy, safety, immunogenicity, and PK endpoints.
Samsung Bioepis' Biosimilar Portfolio
OPUVIZ is the second ophthalmology biosimilar approved in Europe within the portfolio developed by Samsung Bioepis (search), with commercialization rights held by Biogen. This portfolio includes BYOOVIZ™ (ranibizumab), BENEPALI™ (etanercept), IMRALDI™ (adalimumab), and FLIXABI™ (infliximab). Samsung Bioepis and Biogen entered into a commercialization agreement in November 2019 for two ophthalmology biosimilar candidates, BYOOVIZ (SB11, ranibizumab) and OPUVIZ (SB15, aflibercept), across the US, Canada, Europe, and other markets.