Mumbai, December 17, 2025: Global pharma major Lupin Limited (Lupin) today 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^TM, 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.

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.
To know more, visit www.lupin.com or follow us on LinkedIn  https://www.linkedin.com/company/lupin

For further information or queries please contact:
Rajalakshmi Azariah
Vice President & Global Head – Corporate Communications, Lupin
rajalakshmiazariah@lupin.com