Lupin has received a positive CHMP opinion for its biosimilar ranibizumab (Ranluspec™), covering vial and syringe formats. The drug treats retinal conditions like AMD, DME, and RVO. This regulatory milestone positions Lupin to expand in Europe’s ophthalmology market, offering affordable biologics and strengthening its biosimilars portfolio.
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Global pharma major Lupin Limited has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for its biosimilar ranibizumab (Ranluspec™). This milestone paves the way for Lupin to expand its footprint in the European ophthalmology market.
Key Highlights
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Regulatory Milestone: The CHMP’s positive opinion covers both vial and pre-filled syringe presentations of Ranluspec™.
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Therapeutic Scope: Ranibizumab is a recombinant humanized monoclonal antibody fragment that inhibits VEGF-A, used to treat neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), proliferative diabetic retinopathy (PDR), and **choroidal neovascularization (CNV).
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Market Potential: A positive CHMP opinion is often a precursor to final EMA approval, which would allow Lupin to market Ranluspec™ across the EU.
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Strategic Expansion: This development strengthens Lupin’s biosimilars portfolio, aligning with its global strategy to deliver affordable biologics in high-demand therapeutic areas.
Why It Matters
The CHMP’s endorsement represents a critical step toward commercialization in Europe, offering patients access to cost-effective treatment options for serious retinal disorders while reinforcing Lupin’s position in the biosimilars market.
Sources: Lupin Press Release, PublicNow, FilingReader
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