CHMP Issues Positive Opinion for Samsung Bioepis and Biogen's Biosimilar Aflibercept, OPUVIZ™

Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) revealed that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a favorable opinion on OPUVIZ™ 40 mg/mL solution for injection in a vial, which is a biosimilar to Eylea2 (aflibercept), also referred to as SB15.

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OPUVIZ has received a recommendation for approval for adult patients in the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema from retinal vein occlusion (RVO; branch or central RVO), visual impairment related to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV).

"We are thrilled that our second ophthalmology biosimilar, OPUVIZ, has been recommended for approval in Europe. This marks a notable achievement for Samsung Bioepis and, more importantly, provides a critical step forward in making essential treatments more accessible for individuals with retinal disorders," stated Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. "The positive opinion highlights not only our dedication to innovation but also our mission to ensure more patients have access to biologic therapies. Our work will continue to focus on transforming the delivery of biologic therapies to patients and improving patient lives through innovative applications of science and technology," she added.

"We are delighted by the favorable CHMP recommendation for OPUVIZ in Europe and its potential as a significant therapeutic option for those affected by retinal vascular disorders," commented Ian Henshaw, Global Head of Biosimilars at Biogen. "Biosimilars have the opportunity to expand access and provide substantial healthcare savings in the treatment of these complex and often debilitating eye diseases."

The positive opinion from the CHMP was supported by a comprehensive body of evidence, including analytical, non-clinical, and clinical data. A randomized, double-masked, parallel-group, multicenter Phase 3 study revealed equivalent efficacy and similar safety, immunogenicity, and pharmacokinetics (PK) profiles between SB15 and reference aflibercept (AFL). The primary endpoint, which measured the change from baseline in best corrected visual acuity (BCVA) at week 8, was met, and the interim analysis at week 32 and the analysis at week 56 demonstrated comparability in additional secondary efficacy, safety, immunogenicity, and PK endpoints between SB15 and AFL.

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According to the data provided by the Synapse Database, As of September 24, 2024, there are 28 investigational drugs for the PGF x VEGF-A target, including 52 indications, 47 R&D institutions involved, with related clinical trials reaching 498, and as many as 842 patents.

AFLIBERCEPT-YSZY is a biosimilar fusion protein drug that targets PGF x VEGF-A. It is used to treat a variety of conditions in therapeutic areas including cardiovascular diseases, congenital disorders, endocrinology and metabolic disease, eye diseases, and other diseases. The active indications for AFLIBERCEPT-YSZY include diabetic retinopathy, diabetic macular oedema, myopic choroidal neovascularization, retinal vein occlusion-related macular edema, and wet AMD.