Xbrane Biopharma AB (Nasdaq Stockholm: XBRANE) has submitted an application for approval (BLA) to the U.S. Food and Drug Administration for its biosimilar candidate to LUCENTIS (ranibizumab).
The original application was submitted in April 2023. In October 2025, the company received a so-called Complete Response Letter (CRL) regarding remaining observations at one of the production facilities. The Authority then required the contract manufacturer to complete all outstanding observations at the production site. The outstanding corrective actions were finalised and verified at the site concerned. Xbrane has therefore resubmitted the BLA. A new review process after resubmission is expected to take around six months.
The company continues to drive the candidate towards approval in the US, with the goal of offering a more cost-effective treatment option for patients with age-related macular degeneration, retinal vein occlusion and myopic choroidal neovascularization, among others.