Global pharmaceutical major Lupin has received approval from the US Food and Drug Administration (FDA) for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar referencing Lucentis, marking a significant milestone in the company’s expanding biosimilars portfolio.
The approval makes Ranluspec the only interchangeable ranibizumab biosimilar in the United States available in both vial and pre-filled syringe (PFS) presentations. Both formats have been approved in the two strengths available for Lucentis — 0.3 mg and 0.5 mg.
Ranibizumab is a recombinant humanised IgG1 monoclonal antibody fragment that targets and inhibits vascular endothelial growth factor A (VEGF-A). The therapy is indicated for the treatment of several retinal disorders, including neovascular (wet) age-related macular degeneration, diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.
Lupin Chief Executive Officer Vinita Gupta 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.”
Lupin Managing Director Nilesh Gupta 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.”
Lupin President Biotechnology Dr Cyrus Karkaria said, “The USFDA 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.”
The approval strengthens Lupin’s presence in the fast-growing biosimilars segment in the U.S. market and underscores the company’s focus on developing complex biologics and specialty products. With Ranluspec becoming its second biosimilar approved in the United States, Lupin is positioning itself to broaden access to cost-effective treatment options for patients suffering from vision-threatening retinal diseases.