Qilu Pharmaceutical Submits China's First Biosimilar Ranibizumab Injection for Marketing Approval

On January 29, the listing application for the ranibizumab injection submitted by Qilu Pharmaceutical was accepted by the Center for Drug Evaluation of the National Medical Products Administration. This is the first biosimilar application for this product in China and is expected to be the first generic version to reach the market.

Ranibizumab Injection is a recombinant anti-VEGF (vascular endothelial growth factor) humanized monoclonal antibody Fab fragment that specifically inhibits human vascular endothelial growth factor A (VEGF-A). It can prevent vascular endothelial cell proliferation, new blood vessel formation, and vascular leakage by binding to and blocking VEGF receptors, and promote the regression of existing new blood vessels. The product indications include wet (neovascular) age-related macular degeneration (AMD), vision impairment caused by diabetic macular edema (DME), diabetic retinopathy (DR), vision impairment caused by macular edema secondary to retinal vein occlusion (RVO), vision impairment caused by choroidal neovascularization, and retinopathy of prematurity (ROP).

In 2012, Qilu Pharmaceutical initiated the development of Ranibizumab Injection. Qilu Pharmaceutical stated that, through small-scale trials, pilot-scale trials, and commercial-scale production, a robust manufacturing process was established. In strict accordance with biosimilar standards, comprehensive quality analyses were conducted on the product’s structure, physicochemical properties, and biological activity. The results confirmed that this product is similar to the originator drug. Additionally, clinical trial results demonstrated that this product is essentially consistent with the originator drug in terms of safety and efficacy.

Editor: Liuli

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