STADA and Xbrane Launch Ximluci (biosimilar, ranibizumab) for Ophthalmic Conditions in the EU
Shots:
- STADA & Xbrane launch Ximluci, a ranibizumab biosimilar in multiple EU countries for several ophthalmic conditions. Ximluci is supplied as a 2.3mg/0.23 mL single-use vial inj. for IVT use
- The marketing authorization was based on data from a comparative analytical assessment & P-III trial of Ximluci vs Lucentis in 580 patients with wet AMD which showed equivalent efficacy & comparable safety to the reference product. The P-III study achieved the 1EPs as the adjusted treatment differences b/w products were within the predefined equivalence margin
- Under the July 2018 agreement, both companies are responsible for the development & manufacturing of the biosimilars while STADA holds the marketing authorization & commercial rights in the EU & other international markets
Ref: Xbrane | Image: Xbrane
Related News:- STADA and Xbrane Receives the MHRA’s Approval for Ximluci (biosimilar, ranibizumab) to Treat Retinal Diseases
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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.
