Drugmaker Lupin has completed advanced clinical trials (Phase III) of its biosimilar version of Roche’s Lucentis (ranibizumab), used to treat age-related macular degeneration (AMD).
About 600 patients from India, the US, the European Union and Russia were on the study, and received either Lupin’s candidate LUBT010 or Lucentis 0.5 mg, as an injection once a month for 12 months. Patients were followed for efficacy, safety and immunogenicity assessment, Lupin said, adding that the data from this study would be part of Lupin’s application for marketing approval with the US Food and Drug Administration and the European Medicines Agency (EMA).
“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,” a note from Lupin said.
It markets the ranibizumab biosimilar in India under the brand name RaniEyes, since 2022. The global study was in line with recommendations from the EMA and USFDA, to evaluate the efficacy, safety, and immunogenicity of LUBT010 versus Lucentis in patients with Neovascular Age-related Macular Degeneration, Lupin said.
The global Phase 3 study marks another significant developmental milestone for Lupin’s Lucentis biosimilar, said Cyrus Karkaria, President, Lupin Biotech. “We will be filing marketing applications for LUBT010 in all major global markets this year,” he added. Nilesh Gupta, Lupin Managing Director said, “We have already commercialised four products to date and there are several more at various stages of clinical trials.”