Lupin has successfully completed a global Phase 3 clinical study of LUBT010, its biosimilar candidate to Lucentis.

The study has achieved its primary endpoint of therapeutic equivalence in visual acuity improvement for wet AMD patients, showcasing comparable safety and immunogenicity between LUBT010 and Lucentis.

Lupin has been marketing its ranibizumab biosimilar in India under the brand name RaniEyes since 2022. Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment used in the treatment of Neovascular Age-related Macular Degeneration (also called wet AMD), Macular Edema Following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Myopic Choroidal Neovascularization (mCNV).

The l Phase 3 study was designed as a global clinical trial, in line with recommendations from EMA and US FDA, to evaluate the efficacy, safety, and immunogenicity of LUBT010 versus Lucentis in patients with Neovascular Age-related Macular Degeneration. A total of 600 patients from India, US, the EU and Russia were randomized in the study, who received either LUBT010 or Lucentis 0.5 mg, administered as an intravitreal injection once a month for 12 months.

Patients were followed for efficacy, safety and immunogenicity assessment. The data from this Phase 3 study will be part of Lupin’s application for marketing approval with the US FDA and the European Medicines Agency (EMA).

“We are very pleased with the positive outcome of the global Phase 3 study, which marks yet another significant developmental milestone for our Lucentis Biosimilar. It is a reaffirmation of our focus on developing high-quality biosimilars, to cater to patient needs. We will be filing marketing applications for LUBT010 in all major global markets this year,” said Dr. Cyrus Karkaria, President of Lupin Biotech.

Commenting on the milestone, Nilesh Gupta, Managing Director, Lupin said, “This achievement of our Biosimilars team demonstrates our capability to develop cutting-edge, cost-effective products. We have already commercialized four products to date and there are several more at various stages of clinical trials. We now look forward to bringing our high-quality Ranibizumab Biosimilar into the global Ophthalmic market, making a positive difference in the lives of our patients worldwide.”