FDA Approves Lucentis® Interchangeable Biosimilar

By Kevin E. Noonan — On August 2nd, Coherus Biosciences announced FDA approval for its Cimerli™ (ranibizumab-eqrn) product, as an interchangeable biosimilar to Genentech/Roche’s Lucentis® (ranibizumab). This biologic drug is a vascular endothelial growth factor (VEGF) inhibitor having five approved indications for Lucentis: the retinal diseases age-related macular degeneration, retinal vein occlusion, diabetic macular edema, diabetic retinopathy, myopic choroidal neovascularization. Cimerli™ has been approved for all of the Lucentis®-approved inductions. FDA approval of Cimerli™ as an interchangeable biosimilar was attributed by Coherus Biosciences to the outcome of a clinical trial, the COLUMBUS-AMD study. The FDA has approved another biosimilar, Byooviz…