Lupin Limited has secured U.S. FDA approval for Ranluspec™ (ranibizumab-hkdz), an interchangeable biosimilar to Genentech’s Lucentis® — a milestone that reshapes patient access to sight-saving biologics across America.
Distinctively, Ranluspec™ stands as the only interchangeable biosimilar ranibizumab approved in the U.S. in both vials and pre-filled syringes, across 0.3 mg and 0.5 mg strengths. Indicated for wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, retinal vein occlusion macular edema, and myopic choroidal neovascularization, the therapy targets VEGF-A — the molecular trigger behind vision-threatening abnormal blood vessel growth.
“This approval deepens our biosimilars portfolio and reflects our advancing capabilities in complex biologics,” said Vinita Gupta, CEO, Lupin. The interchangeable status empowers pharmacists to substitute Ranluspec™ without prescriber intervention, accelerating uptake and expanding affordability for millions.
Written by: Sayan Das
Graphics by: Pramit Hazra
