Following the European Medicines Agency’s (EMA) positive opinion of Rexatilux ranibizumab biosimilar in April 2026, on 21 May 2026, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted apositive opinion, recommending the granting of a marketing authorization for Lupin’s ranibizumab biosimilar, Vislyfa, for the treatment of wet macular degeneration.
Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. Ranibizumab inhibits angiogenesis (the formation of new blood vessels) by inhibiting vascular endothelial growth factor A (VEGF-A), a mechanism similar to bevacizumab [1].
Lupin Europe’s Vislyfa is a biosimilar of Roche/Genentech’s Lucentis (Ranibizumab). Vislyfa will be available as a 10 mg/mL solution for injection and must be administered by a qualified ophthalmologist experienced in intravitreal injections.
Approved indications of Vislyfa:
- neovascular (wet) age-related macular degeneration (AMD)
- visual impairment due to diabetic macular oedema (DME)
- proliferative diabetic retinopathy (PDR)
- macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)
- choroidal neovascularisation (CNV).
The CHMP’s positive opinion for Vislyfa was based on a comprehensive data package demonstrating high analytical similarity and equivalent clinical performance to the reference medicine, Lucentis. As a biosimilar, Vislyfa’s approval relies on proving it is highly comparable to the original biological, rather than conducting entirely new efficacy trials for each indication.
Two brands, same molecule
Lupin markets its ranibizumab biosimilar under two different names – Ranluspec and Vislyfa – tailored for specific geographic markets and commercial partnerships.
- Ranluspec is the brand name designated for the US and several global markets. In the US, it holds interchangeable biosimilar status, meaning it can be substituted at the pharmacy level without a new prescription. Lupin has partnered with Sandoz to commercialise Ranluspec in Europe and other international regions.
- Vislyfa is the brand name Lupin uses specifically for the European Union (EU) and certain other international markets. This second brand name 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.
European landscape for ranibizumab biosimilars
Vislyfa’s positive CHMP opinion adds to a growing list of ranibizumab biosimilars approved 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) [2] and Vislyfa (newly recommended). Others include Intas’ recently approved Rexatilux [3], 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.
There were no biosimilars approved by the EMA in January and March 2026.
Related article
FDA approves third interchangeable ranibizumab biosimilar Nufymco
References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ranibizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jun 12]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-ranibizumab
2. GaBI Online - Generics and Biosimilars Initiative. EC approves golimumab biosimilar Gotenfia and ranibizumab biosimilar Ranluspec [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jun 12]. Available from: www.gabionline.net/biosimilars/news/ec-approves-golimumab-biosimilar-gotenfia-and-ranibizumab-biosimilar-ranluspec
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval for ranibizumab biosimilar Rexatilux [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jun 12]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-for-ranibizumab-biosimilar-rexatilux
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