The European Commission (EC) has approved OPUVIZ (aflibercept biosimilar, previously known as SB15) for the treatment of several retinal disorders. Developed by Samsung Bioepis, OPUVIZ offers a new treatment option for adult patients suffering from neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular edema secondary to retinal vein occlusion (RVO), visual impairment due to diabetic macular edema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV).
The approval is based on a comprehensive review of analytical, non-clinical, and clinical data, including a Phase 3 study. This randomized, double-masked, parallel-group, multicenter trial demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics (PK) profiles between SB15 and reference aflibercept. The primary endpoint, change from baseline in best corrected visual acuity (BCVA) at week 8, was successfully met. Interim analyses at 32 weeks and a final analysis at 56 weeks further confirmed the comparability of OPUVIZ to aflibercept across secondary efficacy, safety, immunogenicity, and PK endpoints.
"Retinal disorders are affecting millions of people’s lives in Europe, yet many patients face barriers to treatment due to high costs," said Byoungin Jung, Vice President, Regulatory Affairs at Samsung Bioepis. "The EC approval for OPUVIZ represents a major step toward our goal of expanding access to vital biologic therapies for those in need. We will continue working to expand access to our quality-assured, safe and effective biosimilars to improve patients' quality of life and support sustainability of healthcare systems."
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."
OPUVIZ marks the second ophthalmology biosimilar approved in Europe from Samsung Bioepis, with commercialization rights held by Biogen. Their portfolio includes BYOOVIZ™ (ranibizumab), BENEPALI™ (etanercept), IMRALDI™ (adalimumab) and FLIXABI™ (infliximab).
