India-based global pharmaceutical company Lupin Limited (BSE: 500257) (NSE: LUPIN) announced on Thursday that the US Food and Drug Administration (FDA) has approved its ranibizumab, Ranluspec (ranibizumab-hkdz), as an interchangeable biosimilar referencing to Genentech's Lucentis.

Lupin says that 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 humanised 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 oedema following retinal vein occlusion, diabetic macular oedema, diabetic retinopathy, and myopic choroidal neovascularisation.