Samsung Bioepis and Biogen Get CHMP Nod for Aflibercept Biosimilar OPUVIZ™

INCHEON, South Korea and CAMBRIDGE, MA, USA I September 20, 2024 I Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) have announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a favorable opinion for OPUVIZ™ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea (aflibercept), also identified as SB15.

OPUVIZ has been recommended for approval for adult patients in Europe for the treatment of various retinal disorders. These include 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).

Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis, expressed the significance of this achievement. "We are pleased to have our second ophthalmology biosimilar OPUVIZ recommended for approval in Europe. This marks another significant milestone for Samsung Bioepis and, more importantly, for people living with retinal disorders as we are making a step forward in enhancing the availability of essential treatments,” she remarked. Jung emphasized the company's dedication to innovation and ensuring access so that more patients can benefit from biologic therapies. She further added that their work continues to focus on transforming the way biologic therapies reach patients and improving patients' lives through pioneering and innovative science and technology.

Ian Henshaw, Global Head of Biosimilars at Biogen, echoed similar sentiments. "We are excited about the positive CHMP recommendation for OPUVIZ in Europe and its potential to serve as a meaningful therapeutic option for individuals impacted by retinal vascular disorders," he stated. Henshaw highlighted the potential of biosimilars to broaden access and offer significant healthcare savings by treating complex and often debilitating ophthalmic diseases.

The CHMP’s positive opinion is based on comprehensive evidence, including analytical, non-clinical, and clinical data. In a randomized, double-masked, parallel-group, multicenter Phase 3 study, OPUVIZ demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics (PK) profiles to the reference aflibercept (AFL). The primary endpoint was achieved, showing a change from baseline in best corrected visual acuity (BCVA) at week 8. Additionally, the results from the 32-week interim and 56-week analyses demonstrated comparability in secondary efficacy, safety, immunogenicity, and PK endpoints between SB15 and AFL.

The CHMP’s positive opinion will now be forwarded to the European Commission (EC), which will decide on granting marketing authorization for OPUVIZ. If approved by the EC, OPUVIZ would become the second ophthalmology biosimilar approved in Europe and the fifth biosimilar in Samsung Bioepis' portfolio, which is commercialized by Biogen. This portfolio includes BYOOVIZ™ (ranibizumab), BENEPALI™ (etanercept), IMRALDI™ (adalimumab), and FLIXABI™ (infliximab). In November 2019, Samsung Bioepis and Biogen entered a commercialization agreement for two ophthalmology biosimilar candidates, BYOOVIZ (SB11, ranibizumab) and OPUVIZ (SB15, aflibercept), covering the U.S., Canada, Europe, Japan, and Australia.

The pivotal Phase 3 study of SB15 was a robust clinical trial conducted at 56 centers across 10 countries from June 2020 to March 2022, including follow-up through 56 weeks. Among the 549 screened participants, 449 treatment-naive nAMD patients aged 50 years and older were randomized to receive either SB15 or AFL. At Week 32, patients were re-randomized to continue their initial treatment or switch, resulting in three treatment groups. A total of 425 patients completed the 56-week study. Key efficacy endpoints were changes from baseline in BCVA, central subfield thickness (CST), and the proportion of patients with intra or sub-retinal fluid.

Samsung Bioepis, established in 2012, aims to realize accessible healthcare through innovations in product development and a firm commitment to quality. The company advances a broad pipeline of biosimilar candidates covering various therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology.

Founded in 1978, Biogen is a biotechnology company dedicated to delivering new medicines to transform patients’ lives. The company leverages a deep understanding of human biology to advance treatments that deliver superior outcomes, balancing bold risks with return on investment for long-term growth.