Swedish biosimilars developer Xbrane Biopharma AB (STO:XBRANE) said on Thursday that it has resubmitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its biosimilar candidate to LUCENTIS (ranibizumab).

The original filing was submitted in April 2023, with the programme receiving a Complete Response Letter in October 2025 related to observations at a contract manufacturing site.

The required corrective actions at the production facility have now been completed and verified, enabling resubmission of the application. The FDA is expected to undertake a new review process lasting approximately six months following the resubmission.

Xbrane continues to pursue US approval with the objective of providing a more cost-effective treatment option for conditions including age-related macular degeneration, retinal vein occlusion, and myopic choroidal neovascularisation.