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Stada and Xbrane Get EU Approval for Lucentis Biosimilar for Eye Disease

Stada and Xbrane Get EU Approval for Lucentis Biosimilar for Eye Disease

The European Commission has granted a marketing authorization to Stada and Xbrane’s Ximluci (ranibizumab), a biosimilar of Novartis’ Lucentis (ranibizumab), to treat retinal vascular disorders.

Ximluci is an anti-vascular endothelial growth factor drug for treating wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, retinal vein occlusion and visual impairment due to choroidal neovascularization in adults.

The companies jointly developed the product following a July 2018 collaboration and manufacturing agreement, but Stada holds the marketing authorizations and the commercial rights.

About Stada Arzneimittel AG

Stada Arzneimittel AG is a pharmaceutical company based in Bad Vilbel, Germany which specializes in the production of generic and over-the-counter drugs. Commonly known products produced by Stada are Stada-brand acetaminophen and lactulose, Grippostad-C cold medicine and Ladival sun protection products. Stada is involved in various charity projects and sponsoring activities.

About Xbrane Biopharma AB

Xbrane Biopharma AB, formerly Xbrane Bioscience AB, is a Sweden-based provider of biotechnology research and development services. It develops biogenerics for injectable slow release drugs and high-yield protein expression technology for the development of biosimilars. The Company's main products are Sperotide, a generic on the originator drug marketed under the trademarks Decapeptyl, Trelstar and Pamorelin, as well as Xlucane, a biosimilar on the originator drug sold under the trademark Lucentis.

November 14, 2022

https://www.fdanews.com/

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