Ranibizumab biosimilar LUBT010 (Lupin) reaches primary endpoint in global Phase 3 study

Lupin noted that the Phase 3 study was designed as a global clinical trial, in line with recommendations from the EMA and FDA. Image credit: ©Chaosamran_Studio – stock.adobe.com

Lupin has successfully completed a global, phase 3 clinical study of LUBT010. This candidate is a ranibizumab biosimilar to Lucentis. The study achieved its primary endpoint, which was equivalence in visual acuity improvement for wet age-related macular degeneration (AMD) patients, showcasing comparable safety and immunogenicity between LUBT010 and Lucentis.

Since 2022, Lupin has been marketing its ranibizumab biosimilar in India under the brand name RaniEyes. Ranibizumab is used in the treatment of wet AMD, macular oedema following retinal vein occlusion (RVO), diabetic macular oedema (DME), diabetic retinopathy (DR) and myopic choroidal neovascularisation (mCNV).¹

In a press release¹, Lupin noted that the Phase 3 study was designed as a global clinical trial, in line with recommendations from European Medicines Agency (EMA) and FDA in the United States. The trial was designed to evaluate the efficacy, safety, and immunogenicity of LUBT010 versus Lucentis in patients with wet AMD. A total of 600 patients from locations in India, the US, the EU, and Russia were randomised in the study, who received either LUBT010 or Lucentis 0.5 mg. Both treatments were administered as an intravitreal injection once a month for 12 months. Patients were followed for efficacy, safety and immunogenicity assessment.

Dr Cyrus Karkaria, President of Lupin Biotech, commented on this milestone¹ and next steps in the company's press release, saying, “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.”

Similarly, Nilesh Gupta, Managing Director of Lupin, noted the potential impact on patients this biosimilar may have, saying, “This achievement of our Biosimilars team demonstrates our capability to develop cutting-edge, cost-effective products. We have already commercialised 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.”

The data gathered during this Phase 3 study will be part of Lupin’s application for marketing approval with the FDA and the EMA.

Reference

1. Lupin Announces Successful Completion of Phase 3 Trials for Lucentis® Biosimilar. Global Pharma major Lupin Limited. August 5, 2024. Accessed August 5, 2024. https://www.lupin.com/lupin-announces-successful-completion-of-phase-3-trials-for-lucentis-biosimilar/