European Commission Approves Lupin’s Biosimilar Ranibizumab, Ranluspec®

European Commission Approves Lupin’s Biosimilar Ranibizumab, Ranluspec®

By, Admin 24 February 2026

Lupin Limited has received approval from the European Commission for its biosimilar ranibizumab, Ranluspec, available in both vials and pre-filled syringes.

The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), clearing the way for commercialization across the European Union.

About Ranibizumab

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that inhibits vascular endothelial growth factor A (VEGF-A), a key driver of abnormal blood vessel growth and leakage in retinal diseases.

It is indicated for the treatment of:

  • Neovascular (wet) age-related macular degeneration (AMD)
  • Macular edema following retinal vein occlusion (RVO)
  • Diabetic macular edema (DME)
  • Proliferative diabetic retinopathy (PDR)
  • Choroidal neovascularization (CNV)

By targeting VEGF-A, ranibizumab helps reduce pathological neovascularization and fluid accumulation, preserving vision in patients with retinal vascular disorders.

Strategic Importance for Lupin

According to Thierry Volle, President EMEA and Emerging Markets at Lupin, the approval highlights the company’s scientific and manufacturing capabilities and reinforces its commitment to expanding access to high-quality biologic therapies globally.

Dr. Cyrus Karkaria, President Biotechnology at Lupin, described the decision as a milestone validating the company’s standards in biosimilar development and its broader mission to make advanced biologics more accessible and affordable.

The approval strengthens Lupin’s growing biosimilars portfolio and enhances its presence in regulated European markets.

Commercialization Plan in Europe

Lupin’s biosimilar ranibizumab will be commercialized by:

  • Sandoz across the European Union (excluding Germany)
  • Both Sandoz and Biogaran in France

This partnership-driven strategy leverages established commercial infrastructures to accelerate market access and uptake.

Expanding Access to Ophthalmology Biologics

The European Commission’s approval of Ranluspec® marks another step in increasing competition within the ophthalmology biologics market. Biosimilars such as ranibizumab aim to improve affordability while maintaining comparable efficacy and safety standards to reference products.

For patients with chronic retinal diseases requiring long-term intravitreal therapy, broader biosimilar availability may contribute to enhanced access and sustainability of care across Europe.

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