Lupin Limited has secured approval from the European Commission for its biosimilar ranibizumab, marketed as Ranluspec™. This approval covers both vial and pre-filled syringe presentations, following a positive opinion from the Committee for Medicinal Products for Human Use. The drug is indicated for severe eye conditions, including wet age-related macular degeneration. Lupin emphasizes that this achievement highlights its strong scientific capabilities and commitment to providing affordable biologic therapies globally.
Lupin Gains Key European Regulatory Approval
Global pharmaceutical company Lupin Limited announced on February 23, 2026, that it has received the formal approval from the European Commission for its biosimilar product, Ranluspec™ (ranibizumab). This product is available in both vials and pre-filled syringes.
The approval follows a positive assessment from the Committee for Medicinal Products for Human Use and is a significant milestone for Lupin’s biotechnology division. Dr. Cyrus Karkaria, President of Biotechnology at Lupin, stated that this validates the company’s commitment to making advanced biologic therapies more accessible.
Indications and Commercialization Strategy
Ranibizumab is a crucial therapy indicated for treating several serious ocular conditions. These include neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, proliferative diabetic retinopathy, and choroidal neovascularization. Thierry Volle, President EMEA and Emerging Markets, expressed pleasure, noting the approval underscores the strength and quality of Lupin’s scientific and manufacturing excellence.
Regarding commercial rollout, Lupin’s biosimilar ranibizumab will be marketed by Sandoz across the European Union, with the exception of Germany. In France, the product will be commercialized through a dual partnership involving Sandoz and Biogaran.
About Lupin’s Global Footprint
Lupin Limited is headquartered in Mumbai, India, and maintains a global presence, distributing products in over 100 markets. The company specializes in various pharmaceutical areas, including branded/generic formulations and biotechnology products. Lupin operates 15 state-of-the-art manufacturing sites and 7 research centers globally, supported by a workforce exceeding 24,000 professionals.
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