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. This approval expands treatment options for several retinal disorders affecting millions across Europe.
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 secondary to retinal vein occlusion (RVO; branch or central RVO), visual impairment due to diabetic macular edema (DME), and visual impairment due to myopic choroidal neovascularization (myopic CNV).
Clinical Equivalence Demonstrated
The EC's decision was based on a comprehensive review of analytical, non-clinical, and clinical data. A pivotal Phase 3 trial, designed as a randomized, double-masked, parallel-group, multicenter study, compared OPUVIZ (SB15) with reference aflibercept. The study successfully demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics (PK) profiles between the two. The primary endpoint, change from baseline in best corrected visual acuity (BCVA) at week 8, was met. Interim analysis at 32 weeks and a final analysis at 56 weeks confirmed comparability across secondary efficacy, safety, immunogenicity, and PK endpoints.
Addressing Unmet Needs
Byoungin Jung, Vice President, Regulatory Affairs at Samsung Bioepis, emphasized 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, highlighted the potential impact on healthcare systems, noting, “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.”
Expanding Biosimilar Portfolio
OPUVIZ represents the second ophthalmology biosimilar approved in Europe within Samsung Bioepis' portfolio, with Biogen holding commercialization rights. The 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), in the US, Canada, Europe, and certain other markets.
