Lupin receives positive EMA comittee opinion for eye therapy Ranluspec

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-12-17 07:28 GMT | Update On 2025-12-17 07:28 GMT

Mumbai: 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, for both vial and pre-filled syringe presentations.

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A (VEGF-A). Its indications encompass the treatment of patients with 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).

The positive CHMP opinion is based on a demonstration of similarity to the reference product, including an analytical similarity assessment and a 600-patient global phase III clinical trial in patients with Neovascular AMD, conducted in the US, EU, Russia, and India.

Thierry Volle, President EMEA and Emerging Markets, Lupin, said, “We are very pleased with the CHMP’s positive opinion for ranibizumab. This recognition underscores the quality of Lupin’s Biologics development and manufacturing as well as our relentless pursuit of affordable solutions that transform patient care.”

The CHMP positive opinion will now be considered by the European Commission (EC). Once approved, the EC will grant a centralized marketing authorization for EU member countries. As per the recently announced agreement, Lupin’s biosimilar ranibizumab will be commercialized by Sandoz Group AG across the European Union (excluding Germany). In France, the product will be commercialized by two companies, Sandoz AG and Biogaran.

Lupin Limited is a global pharmaceutical company 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. The company has 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.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Lupin receives positive EMA comittee opinion for eye therapy Ranluspec

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