EMA Recommends Approval for Ranibizumab Biosimilar Vislyfa, Expanding European Treatment Options for Retinal Diseases
核心洞察
The EMA's CHMP has issued a positive opinion recommending approval of Lupin Europe (搜索)'s Vislyfa (搜索), a ranibizumab biosimilar referencing Roche/Genentech (搜索)'s Lucentis.
Vislyfa (搜索) is indicated for wet AMD, diabetic macular oedema (搜索), proliferative diabetic retinopathy (搜索), macular oedema secondary to RVO, and choroidal neovascularisation (搜索).
The recommendation was based on a comprehensive data package demonstrating high analytical similarity and equivalent clinical performance to the reference medicine.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Vislyfa (搜索), a ranibizumab biosimilar developed by Lupin Europe (搜索). The product references Roche/Genentech (搜索)'s Lucentis (ranibizumab), a monoclonal antibody fragment that inhibits angiogenesis by targeting vascular endothelial growth factor A (VEGF-A (搜索)).
Vislyfa (搜索) will be available as a 10 mg/mL solution for injection and must be administered by a qualified ophthalmologist experienced in intravitreal injections. The CHMP's positive opinion covers the full range of Lucentis indications: neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (搜索) (DME), proliferative diabetic retinopathy (搜索) (PDR), macular oedema secondary to retinal vein occlusion (搜索) (branch RVO or central RVO), and choroidal neovascularisation (搜索) (CNV).
Biosimilarity Data Package
The CHMP's favorable assessment was based on a comprehensive data package demonstrating high analytical similarity and equivalent clinical performance to the reference medicine, Lucentis. As a biosimilar, Vislyfa (搜索)'s approval pathway relies on proving it is highly comparable to the original biologic, rather than requiring entirely new efficacy trials for each indication.
A Two-Brand Strategy
Lupin markets its ranibizumab biosimilar under two distinct brand names tailored for specific geographic markets and commercial partnerships. Ranluspec is the brand designated for the US and several global markets, where it holds interchangeable biosimilar status allowing pharmacy-level substitution without a new prescription. Lupin has partnered with Sandoz to commercialize Ranluspec in Europe and other international regions.
Vislyfa (搜索), by contrast, is the brand name Lupin uses specifically for the European Union and certain other international markets. This second brand allows Lupin to market the same molecule independently or through different channels in regions where Sandoz does not hold exclusive rights. Despite the different names, both medications share the same active ingredient and are highly similar biosimilars to Lucentis.
Growing European Biosimilar Landscape
Vislyfa (搜索)'s positive CHMP opinion adds to a growing roster of ranibizumab biosimilars in Europe. To date, eight such biosimilars have been approved, including both of Lupin's products — Ranluspec, approved by the EU on 10 February 2026, and the newly recommended Vislyfa. Other approved ranibizumab biosimilars include Intas' recently approved Rexatilux, Qilu Pharma's Rimmyrah and Midas Pharma's Epruvy (both approved in 2024), Bioeq/Teva's Ranivisio and Stada's Ximluci (both approved in 2022), and Samsung Bioepis' Byooviz (approved in 2021).
This duplicate registration strategy is commonly used by drug manufacturers to navigate overlapping commercial agreements, distribute the same medicine through different networks, or work around local trademark restrictions. Notably, there were no biosimilars approved by the EMA in January and March 2026, making the Vislyfa (搜索) recommendation a significant regulatory milestone in the current year's biosimilar approvals landscape.