Xbrane Reports the US FDA Acceptance of BLA for Lucentis Biosimilar to Treat Serious Eye Diseases
Shots:
- The US FDA has accepted the BLA filings for Lucentis (ranibizumab) biosimilar candidates for serious eye diseases i.e., wAMD, macular edema, following retinal vein occlusion & myopic choroidal neovascularization. The US FDA set a BsUFA date of April 2024
- The filing was based on the comprehensive comparative analytical assessment & positive data from a randomized, double-masked, multi-center study evaluating ranibizumab biosimilar in patients with wAMD. The biosimilar candidate was co-developed by Xbrane & STADA
- The biosimilar candidate met the 1EPs in the study & showed an equivalent efficacy measured in improvement in BCVA at 8wk. over Lucentis with no clinical differences in 2EPs regarding PK, safety & immunogenicity over Lucentis
Ref: Xbrane | Image: Xbrane
Related News:- Samsung Bioepis and Biogen Announces FDA Filing Acceptance of Lucentis' Biosimilar- SB11 for Retinal Vascular Disorders
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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.
