Qilu Pharmaceutical's Ranibizumab Biosimilar Receives EMA Approval for Multiple Ophthalmic Indications

Jan 16, 2024 15:30 CST Updated 15:30

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

▎Edited by the WuXi AppTec content team

On January 15, Qilu Pharmaceutical Co., Ltd. announced itsRanibizumab Injection BiosimilarReceived marketing approval from the European Medicines Agency (EMA).Public information shows that this isA Recombinant Anti-VEGF Humanized Monoclonal Antibody Fab Injection, with the R&D code QL1205.

Ranibizumab Injection is an ophthalmic recombinant anti-VEGF (vascular endothelial growth factor) humanized monoclonal antibody Fab fragment that specifically inhibits human vascular endothelial growth factor A (VEGF-A).Ranibizumab can inhibit vascular endothelial cell proliferation, neovascularization, and vascular leakage by binding to and blocking VEGF receptors, and promote the regression of existing neovascularization.The original research product of this drug was developed by Genentech, a subsidiary of Roche, and Novartis.（Novartis）Co-developed and already approved in China for multiple indications, including wet age-related macular degeneration, diabetic macular edema, macular edema secondary to retinal vein occlusion, choroidal neovascularization, diabetic retinopathy, retinopathy of prematurity, etc.

According to the introduction in the press release by Qilu Pharmaceutical Co., Ltd., the company'sRanibizumab Injection BiosimilarFor the treatment of wet (neovascular) age-related macular degeneration, vision impairment caused by diabetic macular edema, diabetic retinopathy (proliferative diabetic retinopathy and moderate to severe non-proliferative diabetic retinopathy), vision impairment caused by macular edema secondary to retinal vein occlusion (including branch retinal vein occlusion or central retinal vein occlusion), and vision impairment caused by choroidal neovascularization [CNV, i.e., CNV secondary to pathologic myopia (PM) and other causes].In China, the marketing application for ranibizumab injection submitted by Qilu Pharmaceutical in January 2023 has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).Acceptance, which is currently under review.

According toQilu Pharmaceutical Co., Ltd. stated in its press release that this is theCompany's Biologics Go International for the First Time, marking that the production process and clinical efficacy of Qilu's biosimilar drugs have been recognized in China.International recognition.

References:

[1] Qilu Pharmaceutical's Ranibizumab Injection Approved for Marketing in the EU. Retrieved Jan 15, 2024, from https://mp.weixin.qq.com/s/sHDtFX1exS4tEmQWysxFyw

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