Lupin secures U.S. FDA approval for interchangeable biosimilar Ranibizumab

Ranluspec is the only interchangeable ranibizumab biosimilar approved in the United States in both vial and pre-filled syringe (PFS) presentations

Pharma major Lupin Limited has received approval from the U.S. Food and Drug Administration (FDA) for Ranluspec™ (ranibizumab-hkdz), an interchangeable biosimilar referencing Lucentis (Genentech).

Ranluspec is the only interchangeable ranibizumab biosimilar approved in the United States in both vial and pre-filled syringe (PFS) presentations.

The product is 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 humanized IgG1 monoclonal antibody fragment that inhibits vascular endothelial growth factor A (VEGF-A).

It is indicated for the treatment of neovascular (wet) age-related macular degeneration, diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

Vinita Gupta, CEO, Lupin, said, “As our second U.S. biosimilar Ranibizumab adds depth to our biosimilars portfolio, reflecting our progress in complex biologics while expanding patient access to proven vision therapies.” 

Nilesh Gupta, Managing Director, Lupin, said, “The approval of Ranluspec reinforces our scientific rigor and manufacturing capabilities, advancing our efforts to build a scalable biosimilars portfolio and expanding access to high-quality, affordable therapies.” 

“The U.S. FDA approval of our biosimilar ranibizumab underscores our scientific expertise in biologics development and manufacturing, and reinforces our commitment to expanding access to advanced, affordable therapies for patients worldwide,” said Dr. Cyrus Karkaria, President Biotechnology, Lupin.