STADA and Xbrane Receive EC’s Marketing Authorization of Ximluci (biosimilar, ranibizumab) for Retinal Disorders
Shots:
- The EC has granted marketing authorization for Ximluci, a biosimilar referencing Lucentis with an expected launch in selected European markets early in 2023
- The marketing authorization was based on a comprehensive comparative analytical assessment & P-III study in 580 patients evaluating Ximluci which demonstrated equivalent efficacy and comparable safety to reference Lucentis
- The EC’s centralized marketing authorization is valid in all 27 EU member states, Iceland, Norway & Liechtenstein. In July 2018, STADA & Xbrane collaborated for the development & manufacturing of the finished product where STADA got the commercial rights to the biosimilar across all territories
Ref: STADA | Image: Xbrane
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
