Lupin has received approval from the United States Food and Drug Administration for Ranluspec, an interchangeable biosimilar referencing Lucentis.

Ranluspec is the only interchangeable ranibizumab biosimilar approved in the US in both vial and pre-filled syringe (PFS) formats. The product has been approved in both strengths available for Lucentis, broadening treatment options for patients and healthcare providers.

Ranibizumab is used in the treatment of several retinal disorders, including wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, retinal vein occlusion-related macular edema, and myopic choroidal neovascularization.

Commenting on the approval, Vinita Gupta said the launch strengthens Lupin's biosimilars portfolio and expands patient access to established vision therapies. Nilesh Gupta highlighted that the approval validates the company's scientific and manufacturing capabilities in biologics, while Dr. Cyrus Karkaria said the milestone underscores Lupin's expertise in biologics development and commitment to affordable advanced therapies.