www.fdanews.com/articles/210163-stada-and-xbrane-get-eu-approval-for-lucentis-biosimilar-for-eye-disease
Stada and Xbrane Get EU Approval for Lucentis Biosimilar for Eye Disease
November 14, 2022
The European Commission has granted a marketing authorization to Stada and Xbrane’s Ximluci (ranibizumab), a biosimilar of Novartis’ Lucentis (ranibizumab), to treat retinal vascular disorders.
Ximluci is an anti-vascular endothelial growth factor drug for treating wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, retinal vein occlusion and visual impairment due to choroidal neovascularization in adults.
The companies jointly developed the product following a July 2018 collaboration and manufacturing agreement, but Stada holds the marketing authorizations and the commercial rights.