China-based Qilu Pharmaceutical has announced that its market approval filing for a biosimilar version of Novartis’ (NYSE: NVS) Lucentis (ranibizumab) has been accepted for review by the Center for Drug Evaluation (CDE) in China. Qilu’s biosimilar is the most advanced version of Lucentis currently under development, positioning the company to potentially expand treatment options for patients with various ophthalmic conditions.
Clinical Validation and Biosimilar Development
Qilu Pharmaceutical notes that clinical studies have demonstrated its version of ranibizumab to be non-inferior to the originator in terms of safety and efficacy. Ranibizumab, a vascular endothelial growth factor A antagonist, produces clinical benefits by inhibiting angiogenesis, thereby reducing abnormal blood vessel development. This mechanism is crucial in treating conditions such as wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and other retinal diseases.
Market and Regulatory Context
Novartis first introduced Lucentis to China in December 2011, with multiple indication approvals including wAMD, DME, diabetic retinopathy (DR), macular edema secondary to retinal vein occlusion (RVO), choroidal neovascularization, and retinopathy of prematurity (ROP). The drug was included on China’s National Reimbursement Drug List (NRDL) in 2019, highlighting its importance in the treatment landscape. Qilu’s biosimilar aims to provide a cost-effective alternative while maintaining high standards of therapeutic efficacy and safety.-Fineline Info & Tech
