Lupin Receives European Commission Approval For Biosimilar Ranibizumab

Global pharma major Lupin Limited (Lupin) today announced that it has received the approval from European Commission for its biosimilar ranibizumab, Ranluspec (for vials and pre-filled syringes), following the recent positive opinion from the Committee for Medicinal Products for Human Use.

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A. Its indications encompass the treatment of patients with 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, Lupin , said, “We are very pleased to receive the European Commission approval for ranibizumab. This achievement underscores the strength and quality of our scientific capabilities and manufacturing excellence. We remain firmly committed to expanding access to innovative, high quality, and affordable biologic therapies for underserved patients worldwide.”

The approval from the European Commission for our biosimilar ranibizumab is a milestone that validates our unwavering commitment and scientific standards to making advanced biologic therapies more accessible,” said Dr. Cyrus Karkaria, President Biotechnology, Lupin.

Lupin’s biosimilar ranibizumab will be commercialized by Sandoz across the European Union (excluding Germany). In France, the product will be commercialized by two companies, Sandoz and Biogaran.

About Lupin
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. For more information, visit www.lupin.com.