Lupin Limited announced that the FDA has approved its ranibizumab, Ranluspec™ (ranibizumab-hkdz), as an interchangeable biosimilar referencing to Lucentis® (Genentech).
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 humanized 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 edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, 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.
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