EC Approves Samsung Bioepis and Biogen's Aflibercept Biosimilar, OPUVIZ

Samsung Bioepis Co., Ltd. and Biogen Inc. recently announced that the European Commission (EC) has approved their new biosimilar, OPUVIZ™ 40 mg/mL solution for injection in a vial. This biosimilar references the drug Eylea (aflibercept) and is intended for various ophthalmic conditions. These conditions include 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 neovascularization (myopic CNV).

Retinal disorders impact millions of individuals across Europe, and many patients face challenges in accessing treatments due to high costs. Byoungin Jung, Vice President of Regulatory Affairs at Samsung Bioepis, emphasized the significance of this approval, noting that it represents a pivotal step in broadening access to essential biologic therapies. This development aligns with the company's mission to enhance patient quality of life and support the sustainability of healthcare systems by providing safe and effective biosimilars.

Wolfram Schmidt, Head of Europe at Biogen, also expressed enthusiasm for the approval, highlighting its potential to offer a new treatment option for eligible patients. Furthermore, it could alleviate the financial burden associated with retinal conditions. Schmidt reiterated the commitment to their partnership with Samsung Bioepis, celebrating the approval of their fifth biosimilar treatment option in Europe.

The EC's approval was based on comprehensive evidence, including analytical, non-clinical, and clinical data. A Phase 3 study, which was randomized, double-masked, and conducted across multiple centers, confirmed the equivalent efficacy and comparable safety profiles between SB15 (OPUVIZ) and the reference drug aflibercept (AFL). The primary endpoint of the study, which assessed the change from baseline in best corrected visual acuity (BCVA) at week 8, was successfully met. Further analyses at 32 and 56 weeks supported the comparability across secondary efficacy, safety, immunogenicity, and pharmacokinetics (PK) endpoints.

OPUVIZ is now the second ophthalmology biosimilar approved in Europe and the fifth biosimilar developed by Samsung Bioepis with Biogen holding commercialization rights. Other biosimilars in their portfolio include BYOOVIZ™ (ranibizumab), BENEPALI™ (etanercept), IMRALDI™ (adalimumab), and FLIXABI™ (infliximab). In November 2019, Samsung Bioepis and Biogen entered into a commercialization agreement for two ophthalmology biosimilars, BYOOVIZ and OPUVIZ, in various markets including the U.S., Canada, and Europe.

The Phase 3 study for SB15 was conducted from June 2020 to March 2022 across 56 centers in 10 countries. It included a follow-up period of 56 weeks and involved 449 participants aged 50 years and older with treatment-naive neovascular AMD. Participants were randomized to receive either SB15 or AFL. At week 32, patients were re-randomized to either continue their initial treatment or switch from AFL to SB15. The study's key efficacy endpoints were the change from baseline in BCVA, central subfield thickness (CST), and the proportion of patients with intra or sub-retinal fluid.

Samsung Bioepis, established in 2012, is a biopharmaceutical company focused on making healthcare accessible through innovative product development and a commitment to quality. The company aims to lead the biopharmaceutical industry by advancing a diverse pipeline of biosimilar candidates across various therapeutic areas including immunology, oncology, and ophthalmology.

Biogen, founded in 1978, is a biotechnology company dedicated to pioneering innovative science to develop new medicines that transform patients' lives. The company focuses on understanding human biology and leveraging different modalities to create treatments that deliver superior outcomes. Biogen's approach includes taking bold risks balanced with return on investment to ensure long-term growth.

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