On 5 August 2024, Lupin announced the successful completion of a global Phase III clinical study of LUBT010, its biosimilar to Genentech’s Lucentis® (ranibizumab). The study showed that LUBT010 has comparable efficacy, safety and immunogenicity to Lucentis® in patients with wet AMD. The Phase III study data will form part of Lupin’s application for marketing approval with the FDA and the EMA.
Lupin has been marketing LUBT010 in India under the brand name RaniEyes™ since 2022, following India’s Central Drugs Standard Control Organisation granting marketing authorisation for LUBT010 in July 2021. In November 2023, Lupin announced it had executed an agreement with the pharmaceutical manufacturer Amman Pharmaceuticals Industries for exclusive marketing and commercialisation of a biosimilar to Lucentis® (ranibizumab) in the middle east region, including Saudi Arabia and UAE.