The European Commission approves biosimilar referencing aflibercept by Samsung Bioepis
The biosimilar now known by the brand name OPUVIZ was previously known as the biosimilar candidate SB15.
(Image credit: AdobeStock/MakoPoko)
The European Commission (EC) has approved OPUVIZ 40 mg/mL solution for injection in a vial. OPUVIZ is a biosimilar referencing Eylea (aflibercept). The biosimilar has been developed and registered by Samsung Bioepis.
The biosimilar now known by the brand name OPUVIZ was previously known as the biosimilar candidate SB15. It has been 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).1
In the press release1, Byoungin Jung, Vice President, Regulatory Affairs at Samsung Bioepis, spoke to this milestone and the hope it may bring to those patients with retinal disorders saying, “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. 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.”
Similarly, Wolfram Schmidt, Head of Europe at Biogen, a collaborating company on this biosimilar, said, “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. We are delighted to continue our partnership with Samsung Bioepis, with the approval of our fifth biosimilar treatment option in Europe.”1
The EC approval comes after a review of the totality of evidence including analytical, non-clinical data, and clinical data on the SB15 candidate. A randomized, double-masked, parallel group, multicenter Phase 3 study demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics (PK) profiles between SB15 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 SB15 and AFL.1
In the press release1, the companies shared an overview of the state of biosimilars for Samsung Bioepis and Biogen. 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), BENEPALI™ (etanercept), IMRALDI™ (adalimumab) and FLIXABI™ (infliximab). In November 2019, Samsung Bioepis and Biogen announced that they had entered into a commercialization agreement for 2 ophthalmology biosimilar candidates, BYOOVIZ (SB11, ranibizumab) and OPUVIZ (SB15, aflibercept), in the US, Canada, Europe, and certain other markets.
