Lupin Receives USFDA Nod for Interchangeable Ranibizumab Biosimilar Ranluspec
Mumbai: Global pharma major Lupin Limited (Lupin) has announced that the United States Food and Drug Administration (U.S. FDA) has approved its ranibizumab, Ranluspec (ranibizumab-hkdz), as an interchangeable biosimilar referencing 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."
Dr Cyrus Karkaria, President – Biotechnology, Lupin, said, "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."
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
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