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# Xbrane Plans Resubmission of Lucentis Biosimilar by June
- URL: https://www.fdaweb.com/xbrane-plans-resubmission-of-lucentis-biosimilar-by-june/
- Published: 2026-04-01T12:00:00.000Z
- Updated: 2026-09-14T13:36:33.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160917

Xbrane Biopharma said it expects to resubmit a BLA before June for 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.

The filing expectation comes after the company received further clarification from FDA tied to a complete response letter (CRL) issued 10/2025\. According to Xbrane, FDA’s concerns were limited to outstanding observations at a contract manufacturing facility, with no issues raised regarding other aspects of the BLA.

The agency has asked the manufacturer to complete corrective actions related to inspection findings before the application can be resubmitted. Xbrane said those remaining items — linked in part to a second product reviewed during the same inspection — are expected to be resolved and verified by the end of April.

The 2025 FDA action was the company’s second CRL related to the biosimilar. 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.

The company characterizes the current delay as minor and plans to proceed with resubmission shortly after the manufacturing issues are addressed. Once filed, the application is expected to undergo a standard FDA review period of about six months.