Lupin Limited has received approval from the European Commission for its biosimilar ranibizumab, marketed as Ranluspec™, in both vial and pre-filled syringe presentations. The approval follows a positive recommendation from the Committee for Medicinal Products for Human Use, marking an important step in expanding access to biologic treatments for patients across the European Union.
Ranibizumab is a recombinant humanised monoclonal antibody fragment that inhibits vascular endothelial growth factor A (VEGF-A). It is used in the treatment of several serious retinal conditions, including neovascular (wet) age-related macular degeneration, diabetic macular edema, macular edema following retinal vein occlusion, proliferative diabetic retinopathy and choroidal neovascularisation. By addressing these conditions, ranibizumab helps reduce vision loss and improve quality of life for patients affected by retinal diseases.
Thierry Volle, President EMEA and Emerging Markets at Lupin, said the approval reflects the company’s scientific expertise and strong manufacturing capabilities. He added that Lupin remains focused on expanding global access to high-quality and affordable biologic medicines, particularly for patients who have limited treatment options.
Dr. Cyrus Karkaria, President Biotechnology at Lupin, said the approval represents an important milestone in the company’s biosimilars programme. He noted that Lupin is committed to maintaining high scientific and quality standards while improving the availability of advanced therapies across global markets.
Under the commercialisation plan, Lupin’s biosimilar ranibizumab will be marketed in the European Union by Sandoz, except in Germany. In France, the product will be distributed by Sandoz and Biogaran. The launch is expected to support wider patient access to ophthalmology treatments through competitive pricing and reliable supply.
Headquartered in Mumbai, Lupin Limited is a global pharmaceutical company with a presence in more than 100 markets. The company develops and manufactures branded and generic medicines, complex generics, biotechnology products and active pharmaceutical ingredients across multiple therapy areas.
With 15 manufacturing facilities and seven research centres worldwide, Lupin continues to invest in innovation to improve patient outcomes. The European approval for biosimilar ranibizumab highlights Lupin’s growing role in the global biologics space and reinforces its commitment to delivering advanced therapies that are accessible, reliable and affordable for patients around the world.
