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# Xbrane Refiles Lucentis Biosimilar BLA
- URL: https://www.fdaweb.com/xbrane-refiles-lucentis-biosimilar-bla/
- Published: 2025-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:49:41.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158414

Xbrane Biopharma has resubmitted a BLA for its investigational ranibizumab, a biosimilar copy of Genentech’s Lucentis, which is indicated for treating neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. Ranibizumab is an anti-vascular endothelial growth factor therapy that prevents vision loss in patients with retinal vascular disorders which can cause irreversible blindness or visual impairments in adults.

Xbrane originally submitted the BLA 4/2023 and received a complete response letter a year later. In the letter, the agency requested additional information related to the reference standard and follow-up actions from the pre-approval inspections of manufacturing partners’ sites. “Xbrane has since, after alignment with FDA, qualified a new reference standard and worked together with its manufacturing partners to complete the requested follow-up actions,” the company says, noting that the review cycle of a re-submitted BLA is six months.