Global pharmaceutical company Lupin has announced that the United States Food and Drug Administration (FDA) has approved its ranibizumab biosimilar, Ranluspec (ranibizumab-hkdz), as an interchangeable biosimilar referencing Lucentis, developed by Genentech.

Ranluspec is the only interchangeable biosimilar ranibizumab approved in the United States in both vial and Pre-Filled Syringe (PFS) presentations. Both formats have been approved in the two 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 to and inhibits vascular endothelial growth factor A (VEGF-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.

Vinita Gupta, Chief Executive Officer of Lupin, said the approval of Ranibizumab as the company’s second biosimilar in the US market strengthens its biosimilars portfolio and reflects its progress in complex biologics while expanding patient access to established vision therapies.

Nilesh Gupta, Managing Director of Lupin, stated that the approval of Ranluspec highlights the company’s scientific rigor and manufacturing capabilities, supporting its efforts to build a scalable biosimilars portfolio and improve access to high-quality and affordable treatment options.

Dr. Cyrus Karkaria, President – Biotechnology at Lupin, said the US FDA approval underscores the company’s expertise in biologics development and manufacturing and reinforces its commitment to making advanced and affordable therapies accessible to patients globally.