Lupin has received approval from the United States Food and Drug Administration (USFDA) for its ranibizumab, Ranluspec (ranibizumab-hkdz), as an interchangeable biosimilar referencing to Lucentis (Genentech). Ranluspec is the only interchangeable biosimilar ranibizumab approved in the United States in both vials and pre-filled syringes (PFS). Both the vial and PFS presentations are approved in both strengths available for Lucentis, 0.3 mg (0.05 mL of 6 mg/mL), and 0.5 mg (0.05 mL of 10 mg/mL).
Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A. It is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
