Samsung Bioepis and Biogen Announce EC Approval of Eylea Biosimilar Opuviz

Samsung Bioepis and Biogen jointly announced that the European Commission (EC) has granted approval for Opuviz 40 mg/mL for injection in a vial. The biosimilar, also known as SB15, references the established treatment Eylea (aflibercept) and was developed by Samsung Bioepis. The approval covers its use in a range of retinal conditions, including wet age-related macular degeneration (AMD); visual impairment due to macular edema secondary to retinal vein occlusion (RVO; both branch and central); diabetic macular edema (DME); and myopic choroidal neovascularization (myopic CNV).

"Retinal disorders affect millions of people in Europe, and many patients face barriers to accessing effective treatments due to high costs," Byoungin Jung, Vice President, Regulatory Affairs at Samsung Bioepis, said in a company news release. "The EC approval for OPUVIZ marks a significant milestone in our mission to expand access to vital biologic therapies. We are committed to improving patients' quality of life while supporting the sustainability of healthcare systems."

The EC’s approval was based on a comprehensive set of evidence, including analytical, nonclinical, and clinical data from a phase 3 study. This randomized, double-masked, multicenter trial demonstrated that SB15 (Opuviz) is comparable to the reference product aflibercept (AFL) in terms of efficacy, safety, immunogenicity, and pharmacokinetics.

Conducted at 56 centers across 10 countries from June 2020 to March 2022, the trial involved 449 patients with treatment-naive wet AMD. Participants were randomly assigned to receive either SB15 or AFL. At week 32, patients were further re-randomized into three groups: continuing SB15, continuing AFL, or switching from AFL to SB15. The study's primary endpoint—change from baseline in best corrected visual acuity (BCVA) at week 8—was met, with results showing equivalent improvements between SB15 and the reference aflibercept.

Secondary endpoints, including central subfield thickness (CST) changes and the proportion of patients with intra- or sub-retinal fluid, confirmed the biosimilar’s comparability to the reference product. Safety and immunogenicity profiles were found to be consistent across the treatment groups.

The partnership between Samsung Bioepis and Biogen has already resulted in the approval and commercialization of four other biosimilars in Europe, including Byooviz (ranibizumab), Benepali (etanercept), Imraldi (adalimumab), and Flixabi (infliximab). Opuviz is the second ophthalmology biosimilar approved under this collaboration, which aims to expand access to cost-effective treatments in ophthalmology and beyond.