On 2 June 2026, the US Food and Drug Administration (FDA) has approved Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar referencing Roche/Genentech’s Lucentis (ranibizumab). Ranluspec is the first interchangeable biosimilar referencing Lucentis approved in both single-dose vial and single-dose prefilled syringe presentations across its two strengths (0.3 mg and 0.5 mg).
Ranluspec, developed by Lupin Limited, is indicated for the same five retinal conditions as Lucentis: neovascular (wet) age-related macular degeneration (AMD), macular oedema following retinal vein occlusion (RVO), diabetic macular oedema (DME), diabetic retinopathy (DR), and myopic choroidal neovascularization (mCNV).
Dosing regimens mirror those of the reference product, with 0.5 mg administered by intravitreal injection monthly for wet AMD, RVO, and mCNV, and 0.3 mg monthly for DME and DR. For wet AMD, less frequent dosing may be considered after an initial loading phase with regular assessment, though it is noted to be less effective compared with the monthly regimen.
Ranibizumab is a monoclonal antibody fragment derived from the same parent mouse antibody as bevacizumab, it inhibits angiogenesis (the formation of new blood vessels) by blocking vascular endothelial growth factor A (VEGF-A), a mechanism of action similar to bevacizumab [1].
While Ranluspec is the fourth interchangeable ranibizumab biosimilar approved in the US—following Byooviz (ranibizumab-nuna) in 2021 [1], Cimerli (ranibizumab-eqrn) in 2022 [2], and Nufymco (ranibizumab-leyk) in late 2025 [3]— it is distinguished by its dual-presentation availability, which may streamline preparation steps and reduce handling variability in high-volume retinal injection clinics.
The approval was based on a comprehensive analytical, preclinical, and clinical data package demonstrating that ranibizumab-hkdz is highly similar to the reference product, with no clinically meaningful differences in safety, purity, potency, pharmacokinetics, pharmacodynamics, or immunogenicity. The interchangeable designation, granted under the Biologics Price Competition and Innovation Act (BPCIA), allows pharmacists to substitute Ranluspec for Lucentis without prescriber intervention, subject to applicable state pharmacy laws.
Wet AMD alone affects an estimated 1.7 million Americans, and the availability of interchangeable biosimilars in this therapeutic area is viewed as a potential mechanism for improving treatment access and continuity, particularly as the anti-VEGF market continues to evolve.
To date, biosimilar uptake in ophthalmology has been slower than in other therapeutic areas, and the availability of multiple interchangeable options—now including Ranluspec—may gradually influence prescribing and dispensing patterns.
Lupin has not yet disclosed the planned US launch date or the list price for Ranluspec. As with all interchangeable biosimilars, real-world substitution will ultimately depend on state-level pharmacy laws governing automatic switching and on payer formulary placements.
Lupin markets its ranibizumab biosimilar under two distinct brand names tailored for specific geographic markets: Ranluspec for the US and several global markets, and Vislyfa for the European Union and certain other international territories [4].
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References
1. GaBI Online - Generics and Biosimilars Initiative. EC and FDA approval for first ranibizumab biosimilar Byooviz [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 Aug 4]. Available from: www.gabionline.net/biosimilars/news/ec-and-fda-approval-for-first-ranibizumab-biosimilar-byooviz
2. GaBI Online - Generics and Biosimilars Initiative. Progress for Lucentis (ranibizumab) biosimilars in Europe and the US [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 Aug 4]. Available from: www.gabionline.net/biosimilars/news/progress-for-lucentis-ranibizumab-biosimilars-in-europe-and-the-us
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves third interchangeable ranibizumab biosimilar Nufymco [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 Aug 4]. Available from: www.gabionline.net/biosimilars/news/fda-approves-third-interchangeable-ranibizumab-biosimilar-nufymco
4. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval for ranibizumab biosimilar Vislyfa [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 Aug 4]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-for-ranibizumab-biosimilar-vislyfa
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