European Commission approves Opuviz (aflibercept biosimilar)

Opuviz, also known as SB15, is approved 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; branch or central RVO), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV).

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 patient’s quality of life and support sustainability of healthcare systems.” 

The EC approval was based on a totality of evidence including analytical, non-clinical data, and clinical data. A randomized, double-masked, parallel group, multicenter Phase III study demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics (PK) profiles between SB 15 and reference aflibercept (AFL). The primary endpoint was met in terms of change from baseline in best corrected visual acuity (BCVA) at week 8, and the 32-week interim analysis and 56-week analysis demonstrated comparability in other secondary efficacy, safety, immunogenicity, and PK endpoints between SB 15 and AFL.

Opuviz is the second ophthalmology biosimilar approved in Europe and fifth biosimilar in the portfolio developed by Samsung Bioepis with commercialization rights held by Biogen, which includes Byooviz (ranibizumab), Benepaili (etanercept), Imraldi (adalimumab) and Flizabi (infliximab). In November 2019, Samsung Bioepis and Biogen announced that they had entered into a commercialization agreement for two ophthalmology biosimilar candidates, Byooviz (SB11, ranibizumab) and Opuviz (SB15, aflibercept), in the U.S., Canada, Europe and certain other markets.