Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its biosimilar version of Novartis’s blockbuster drug Lucentis (ranibizumab) has received market approval from the National Medical Products Administration (NMPA). This regulatory nod positions the product as the first biosimilar of its kind to be approved in China.
Ranibizumab, a vascular endothelial growth factor (VEGF) A antagonist, is recognized for its clinical benefits in inhibiting angiogenesis, the formation of new blood vessels. Novartis introduced Lucentis to the Chinese market in December 2011, and it has since gained approval for a range of indications, including wet age-related macular degeneration (wAMD), diabetic macular edema (DME), diabetic retinopathy (DR), macular edema due to retinal vein occlusion (RVO), choroidal neovascularization, and retinopathy of prematurity (ROP). The drug is also indicated for the treatment of retinopathy in premature infants, specifically for AP-ROP (acute proliferative ROP) in certain zones and stages.
The biosimilar candidate underwent a rigorous, global Phase III trial, which was multi-center, randomized, double-blinded, and featured two parallel groups with a positive control. The study involved 616 subjects from 97 centers across 11 countries, comparing the efficacy and safety of the biosimilar to that of the originator drug. The primary endpoint results, showing comparable changes in the best-corrected visual acuity (BCVA) letter count between the biosimilar and originator groups at week 8 from baseline, demonstrated bioequivalence in clinical efficacy.- Flcube.com
