CHMP Recommends Aflibercept Biosimilar OPUVIZ for Retinal Disorders
核心洞察
The European Medicines Agency's CHMP has issued a positive opinion for OPUVIZ, an aflibercept biosimilar developed by Samsung Bioepis (搜索) and Biogen.
OPUVIZ is recommended for treating neovascular age-related macular degeneration (搜索), macular edema (搜索) secondary to retinal vein occlusion (搜索), and diabetic macular edema (搜索).
A Phase 3 trial demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics between OPUVIZ and reference aflibercept.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for OPUVIZ, a biosimilar referencing Eylea (aflibercept), developed by Samsung Bioepis (搜索) and Biogen. This decision paves the way for potential marketing authorization in Europe for the treatment of several retinal disorders.
OPUVIZ has been recommended for approval in adult patients for the treatment of neovascular (wet) age-related macular degeneration (搜索) (AMD), visual impairment due to macular edema (搜索) secondary to retinal vein occlusion (搜索) (RVO; branch or central RVO), visual impairment due to diabetic macular edema (搜索) (DME), and visual impairment due to myopic choroidal neovascularization (myopic CNV).
Clinical Trial Data
The CHMP's positive opinion was supported by a comprehensive data package, including analytical, non-clinical, and clinical data. A randomized, double-masked, parallel-group, multicenter Phase 3 study compared OPUVIZ (SB15) to reference aflibercept (AFL) in patients with treatment-naive neovascular AMD. The study, conducted across 56 centers in 10 countries, randomized 449 participants aged 50 years and older in a 1:1 ratio to receive either SB15 (n = 224) or AFL (n = 225).
The primary endpoint, change from baseline in best-corrected visual acuity (BCVA) at week 8, was met, demonstrating equivalent efficacy between SB15 and AFL. Interim analysis at 32 weeks and a final analysis at 56 weeks showed comparable safety, immunogenicity, and pharmacokinetics (PK) profiles between the two groups.
Implications for Treatment
"We are excited about the positive CHMP recommendation for OPUVIZ in Europe and the potential for it to serve as a meaningful therapeutic option for individuals impacted by retinal vascular disorders," said Ian Henshaw, Global Head of Biosimilars at Biogen. He emphasized that biosimilars could broaden access and offer significant healthcare savings in treating complex ophthalmic diseases.
Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis (搜索), highlighted the significance of this milestone, stating, "The positive opinion underscores not only our commitment to innovation but also ensuring access so that more patients can benefit from biologic therapies."
Next Steps
The CHMP’s positive opinion will now be referred to the European Commission (EC), which will decide whether to grant marketing authorization for OPUVIZ. If approved, OPUVIZ would become the second ophthalmology biosimilar approved in Europe within the Samsung Bioepis (搜索) portfolio commercialized by Biogen, joining BYOOVIZ (ranibizumab).