Lupin Successfully Concludes Phase 3 Trial for Lucentis Biosimilar LUBT010

Lupin revealed the conclusion of LUBT010, its biosimilar candidate to Lucentis, in a worldwide Phase 3 clinical investigation. The primary aim of the research, which was to demonstrate therapeutic equivalency in improving visual acuity for individuals with wet AMD, was met, indicating that LUBT010 and Lucentis are similarly safe and immunogenic.

Since 2022, Lupin has been selling its biosimilar ranibizumab in India under the name RaniEyes. For the treatment of Neovascular Age-related Macular Degeneration (also known as wet AMD), Macular Oedema Following Retinal Vein Occlusion (RVO), Diabetic Macular Oedema (DME), Diabetic Retinopathy (DR), and Myopic Choroidal Neovascularisation (mCNV), ranibizumab is a recombinant humanised IgG1 kappa isotype monoclonal antibody fragment. 

In accordance with guidelines from the US FDA and EMA, the Phase 3 research was created as a worldwide clinical trial to assess the immunogenicity, safety, and effectiveness of LUBT010 in comparison to Lucentis in patients with Neovascular Age-related Macular Degeneration. In this trial, 600 patients from Russia, the US, the EU, and India were randomly assigned to receive either 0.5 mg of Lucentis or LUBT010 intravitreally once a month for a period of 12 months. Patients were monitored for safety, effectiveness, and immunogenicity evaluation. Lupin's application for commercial clearance with the US FDA and the European Medicines Agency (EMA) will include results from this Phase 3 research.