Lupin's RanluspecTM Receives U.S. FDA Approval as Interchangeable Biosimilar
Lupin Limited announced U.S. FDA approval for RanluspecTM (ranibizumab-hkdz), an interchangeable biosimilar to Lucentis®. It's the only interchangeable biosimilar ranibizumab approved in the U.S., available in vials and pre-filled syringes. This approval aims to increase patient access to advanced vision therapies.
FDA approval for an interchangeable biosimilar is a major milestone that can significantly impact market share, revenue, and the company's standing in the pharmaceutical industry.
The U.S. FDA approval of RanluspecTM is a significant positive development for Lupin, expanding its biosimilar portfolio and improving patient access to treatments.
Lupin Limited has announced that the United States Food and Drug Administration (U.S. FDA) has approved its ranibizumab, RanluspecTM (ranibizumab-hkdz), as an interchangeable biosimilar referencing Lucentis® (Genentech).
RanluspecTM is noted as the only interchangeable biosimilar ranibizumab approved in the United States, available in both vials and pre-filled syringes. Both presentations are approved in the strengths of 0.3 mg and 0.5 mg, mirroring the available strengths for Lucentis®.
Ranibizumab is a therapeutic agent for treating conditions such as neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization. The approval signifies Lupin's progress in complex biologics and aims to expand patient access to proven vision therapies.
Vinita Gupta, CEO of Lupin, highlighted that RanluspecTM enhances the biosimilars portfolio and reflects progress in complex biologics. Nilesh Gupta, Managing Director, emphasized the approval as a reinforcement of their scientific rigor and manufacturing capabilities, advancing their goal of building a scalable biosimilars portfolio. Dr. Cyrus Karkaria, President Biotechnology, stated that the approval underscores their expertise in biologics development and manufacturing, reinforcing their commitment to accessible, affordable therapies.
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