STADA and Xbrane Receive EMA’s CHMP Positive Opinion for Ximluci (biosimilar, ranibizumab)
Shots:
- The EMA’s CHMP has adopted a positive opinion for Ximluci, a biosimilar referencing Lucentis for wet AMD, DME, PDR, RVO & visual impairment due to CNV. The biosimilar will be available on the UK market shortly
- The opinion was based on the P-III study to evaluate Ximluci which showed a comparable safety & efficacy of Ximluci vs Lucentis for wet AMD. The EC’s centralized marketing authorization will be valid in all 27 EU member states, Iceland, Norway & Liechtenstein
- If Ximluci is approved, it will 1st biosimilar candidate authorized through the partnership & will be developed under Xlucane. In a 2018 agreement with Xbrane, STADA will hold the marketing authorizations & commercial rights to the biosimilar across all territories incl. EU, the US & other countries
Ref: STADA | Image: STADA
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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.
