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At its May meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for Vislyfa (ranibizumab, Lupin Europe GmbH) for the treatment of several retinal conditions, including neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular edema, proliferative diabetic retinopathy, visual impairment due to macular edema secondary to retinal vein occlusion, and visual impairment due to choroidal neovascularization.

The proposed authorization would add another ranibizumab biosimilar option for adults with retinal diseases in which abnormal angiogenesis and vascular leakage can threaten vision.

Vislyfa is a biosimilar to Lucentis (ranibizumab), which was authorized in the European Union in January 2007. Clinical data demonstrate that Vislyfa has comparable quality, safety, and efficacy to the reference product. 

How the Biosimilar Works

Vislyfa contains ranibizumab as its active substance, an anti-neovascularization agent that inhibits vascular endothelial growth factor A (VEGF-A). This mechanism prevents abnormal blood vessel formation that characterizes the approved retinal conditions. Ranibizumab selectively binds to VEGF-A and blocks all active forms of this protein, which plays an essential role in choroidal neovascularization pathogenesis. Choroidal neovascularization involves abnormal blood vessel growth beneath the retina that can lead to vision loss through bleeding, fluid leakage, and scarring.

The medication will be available as a 10 mg/mL solution for injection. It must be administered by qualified ophthalmologists experienced in intravitreal injections, utilizing an individualized PRN (as-needed) dosing regimen based on individual disease activity. 

The CHMP opinion was based on data showing that Vislyfa is highly similar to the reference product Lucentis, with comparable quality, safety, and efficacy. Because Vislyfa is a biosimilar, the central regulatory question is comparability with the authorized ranibizumab reference product rather than new efficacy trials for each retinal indication. 

Safety and Next Steps

No new safety concerns were highlighted in the CHMP summary. EMA said Vislyfa has comparable safety to Lucentis.

Following the CHMP recommendation, the European Commission will issue its final market authorization decision within 67 days. Detailed recommendations on clinical use of this product will be outlined in the summary of product characteristics, which will be published on the EMA website in all official European Union languages following European Commission approval.