Lupin Receives U.S. FDA Approval for Ranluspec TM Biosimilar Injectable
Global pharmaceutical major Lupin Limited announced that the United States Food and Drug Administration (U.S. FDA) has approved its ranibizumab, Ranluspec TM (ranibizumab-hkdz), as an interchangeable biosimilar referencing Lucentis® (Genentech).Ranluspec TM is noted as the only interchangeable biosimilar ranibizumab approved in the United States in both vials and pre-filled syringes (PFS). Both presentations are approved for the strengths available for Lucentis®, specifically 0.3 mg and 0.5 mg, which correspond to 0.05 mL of 6 mg/mL and 10 mg/mL respectively.
Ranibizumab is described as a recombinant humanized IgG1 monoclonal antibody fragment. It binds to and inhibits vascular endothelial growth factor A. The drug is indicated for the treatment of neovascular (wet) age-related macular degeneration, diabetic macular edema, diabetic retinopathy, retinal vein occlusion macular edema, and myopic choroidal neovascularization.
Executives at Lupin highlighted the significance of the approval. Vinita Gupta, CEO of Lupin, stated that this second U.S. biosimilar Ranibizumab adds depth to the company's biosimilars portfolio, reflecting their progress in complex biologics while expanding patient access to proven vision therapies.
Nilesh Gupta, Managing Director at Lupin, added that the Ranluspec approval reinforces the company’s scientific rigor and manufacturing capabilities, advancing efforts toward building a scalable biosimilars portfolio and increasing access to high-quality, affordable treatments. Dr. Cyrus Karkaria, President Biotechnology at Lupin, stated that the U.S. FDA approval of their biosimilar ranibizumab underscores their scientific expertise in biologics development and manufacturing, reinforcing their commitment to expanding access to advanced, affordable therapies for patients worldwide.
About Lupin Limited
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed across over 100 markets. The company specializes in various pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin maintains a strong position in both India and the U.S., focusing on respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health areas. The company operates 15 state-of-the-art manufacturing sites and 7 research centers globally, supported by a workforce of over 24,000 professionals. Lupin is dedicated to improving patient health outcomes through its subsidiaries: Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.LUPIN Stock Price Movement
Lupin Limited shares closed on Thursday, settling at ₹2249.8 after slipping by 0.41% in trading. The equity saw a total traded volume of 663,261 shares during the session.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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