Lupin’s Ranibizumab Biosimilar Advances Toward EU Approval

has cleared a key European regulatory milestone after the European Medicines Agency’s CHMP issued a positive opinion recommending marketing authorisation for Lupin’s biosimilar ranibizumab (Ranluspec) in both vial and pre-filled syringe formats. This opinion is an important step because the final EU-wide approval decision now moves to the European Commission under the centralised authorisation process. Ranibizumab is an ophthalmology biologic used across several retinal conditions, including wet age-related macular degeneration, diabetic macular edema and retinal vein occlusion-related macular edema. Lupin said the CHMP recommendation is supported by a “totality of evidence” package, including analytical similarity work and a 600-patient global Phase III study in neovascular AMD conducted across regions including the US, EU, Russia and India. If the European Commission grants approval, the product can be marketed across EU member countries via a single central authorisation. Commercially, Lupin indicated that Sandoz will handle commercialisation across the European Union excluding Germany, while in France the product will be commercialised by Sandoz and Biogaran. Disclaimer: This post is for informational purposes only and not a recommendation to buy or sell any securities. I, or my family, associates, or relatives, may have a financial interest in the securities mentioned.