India, June 4 -- Lupin Ltd., (NSE: LUPIN) announced that the U.S. FDA has approved Ranluspec (ranibizumab-hkdz), its interchangeable biosimilar to Lucentis (Genentech). The approval covers both vial and pre-filled syringe formats in the same strengths as Lucentis, 0.3 mg and 0.5 mg.
Ranluspec is a recombinant humanized monoclonal antibody fragment that blocks vascular endothelial growth factor A. It is indicated for several vision-threatening conditions, including wet-age related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.
Company executives highlighted the milestone as Lupin's second U.S. biosimilar approval, underscoring its ...