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Lupin Announces Successful Phase 3 Trials for Lucentis® Biosimilar

NextEdge Admin

05 Aug 2024

1 min 48 sec

Lupin Limited announced the successful completion of a global Phase 3 clinical study for LUBT010, its biosimilar candidate to Lucentis, achieving therapeutic equivalence in visual acuity improvement for wet AMD patients. The study, meeting EMA and U.S. FDA guidelines, involved 600 patients from India, the U.S., EU, and Russia, who received either LUBT010 or Lucentis® 0.5 mg via monthly intravitreal injections for 12 months. Both treatments showed comparable safety and immunogenicity.

Since 2022, Lupin has marketed its ranibizumab biosimilar in India under the brand name RaniEyes. Ranibizumab is a monoclonal antibody fragment used for conditions such as Neovascular Age-related Macular Degeneration (wet AMD), Macular Edema Following Retinal Vein Occlusion, Diabetic Macular Edema, Diabetic Retinopathy, and Myopic Choroidal Neovascularization.

Dr. Cyrus Karkaria, President of Lupin Biotech, expressed satisfaction with the positive outcomes, underscoring Lupin's commitment to developing high-quality biosimilars. Nilesh Gupta, Managing Director of Lupin, highlighted the company's success in creating cost-effective products, noting their readiness to file marketing applications for LUBT010 in major global markets this year. This milestone reflects Lupin's dedication to advancing healthcare and improving patients' lives worldwide.